CLASS II ONGOING Device recall · Reported 1 Dec 2021 · FDA Enforcement Report

Endurant IIs Stent Graft System recalled by Medtronic Vascular

Medtronic Vascular is recalling Endurant IIs Stent Graft System, distributed nationwide in the US. The recall was initiated on 15 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number/GTIN Code/Product Description: ESBF2814C103EE 00643169780446 V30609409 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609410 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609411 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609412 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609415 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609417 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609420 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609421 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609423 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616743 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616746 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616748 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E 00643169439993 V30618898 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618899 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618902 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE 00643169780446 V30618963 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618964 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618965 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618966 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618967 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618968 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618969 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618970 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618971 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618972 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618973 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618974 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618975 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618976 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618977 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618978 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618979 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618980 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618982 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618983 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618984 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618988 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618989 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE 00763000098858 V30619120 STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619159 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619161 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625915 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625916 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625917 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625918 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625921 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625935 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625936 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625938 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625941 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625942 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625943 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625944 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625945 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625946 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625947 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625948 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625949 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625950 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625951 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625952 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625953 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625954 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625957 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625958 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625961 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625962 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625963 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625985 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628576 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628577 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628578 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628579 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628580 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628581 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628582 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628583 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628584 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628585 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628586 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628587 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628588 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103E 00643169439979 V30628625 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628639 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628643 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628652 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628654 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628655 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628657 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628658 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628659 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628660 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2314C103EE 00643169780422 V30628737 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628738 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628739 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628740 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628741 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628742 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628743 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628744 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628745 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628746 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628747 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628748 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628750 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628751 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628752 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628753 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628754 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103E 00643169439979 V30629481 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629492 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629493 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629496 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629501 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629503 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629505 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629516 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629517 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629529 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629530 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629531 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629532 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629539 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2814C103EE 00643169780446 V30629760 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629761 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629762 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629763 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629764 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629765 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629766 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629767 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629768 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629770 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629771 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629772 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629773 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF Serial Numbers: V30609409 V30609410 V30609411 V30609412 V30609415 V30609417 V30609420 V30609421 V30609423 V30616743 V30616746 V30616748 V30618898 V30618899 V30618902 V30618963 V30618964 V30618965 V30618966 V30618967 V30618968 V30618969 V30618970 V30618971 V30618972 V30618973 V30618974 V30618975 V30618976 V30618977 V30618978 V30618979 V30618980 V30618982 V30618983 V30618984 V30618988 V30618989 V30619120 V30619159 V30619161 V30625915 V30625916 V30625917 V30625918 V30625921 V30625935 V30625936 V30625938 V30625941 V30625942 V30625943 V30625944 V30625945 V30625946 V30625947 V30625948 V30625949 V30625950 V30625951 V30625952 V30625953 V30625954 V30625957 V30625958 V30625961 V30625962 V30625963 V30625985 V30628576 V30628577 V30628578 V30628579 V30628580 V30628581 V30628582 V30628583 V30628584 V30628585 V30628586 V30628587 V30628588 V30628625 V30628639 V30628643 V30628652 V30628654 V30628655 V30628657 V30628658 V30628659 V30628660 V30628737 V30628738 V30628739 V30628740 V30628741 V30628742 V30628743 V30628744 V30628745 V30628746 V30628747 V30628748 V30628750 V30628751 V30628752 V30628753 V30628754 V30629481 V30629492 V30629493 V30629496 V30629501 V30629503 V30629505 V30629516 V30629517 V30629529 V30629530 V30629531 V30629532 V30629539 V30629760 V30629761 V30629762 V30629763 V30629764 V30629765 V30629766 V30629767 V30629768 V30629770 V30629771 V30629772 V30629773

Quantity recalled419 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0292-2022
FDA event ID: 88951
Recalling firm: Medtronic Vascular, Santa Rosa, CA
Classification: Class II
Status: Ongoing
Recall initiated: 15 Oct 2021
FDA classified: 24 Nov 2021
Reported: 1 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

15 Oct 2021	Recall initiated by company
24 Nov 2021	Classified by FDA	+40 days
1 Dec 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

Product as listed by the FDA

Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF231

Where it was distributed

Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

Nationwide California Florida Georgia Minnesota Missouri North Carolina New Jersey New Mexico Nevada New York Pennsylvania South Carolina Tennessee Texas Virginia West Virginia

Questions about this recall

Why was it recalled?

Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

Which lots are affected?

Model Number/GTIN Code/Product Description: ESBF2814C103EE 00643169780446 V30609409 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609410 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609411 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609412 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609415 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609417 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609420 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609421 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609423 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616743 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616746 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616748 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E 00643169439993 V30618898 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618899 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618902 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE 00643169780446 V30618963 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618964 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618965 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618966 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618967 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618968 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618969 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618970 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618971 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618972 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618973 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618974 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618975 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618976 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618977 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618978 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618979 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618980 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618982 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618983 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618984 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618988 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618989 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE 00763000098858 V30619120 STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619159 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619161 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625915 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625916 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625917 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625918 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625921 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625935 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625936 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625938 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625941 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625942 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625943 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625944 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625945 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625946 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625947 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625948 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625949 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625950 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625951 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625952 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625953 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625954 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625957 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625958 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625961 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625962 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625963 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625985 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628576 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628577 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628578 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628579 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628580 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628581 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628582 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628583 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628584 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628585 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628586 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628587 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628588 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103E 00643169439979 V30628625 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628639 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628643 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628652 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628654 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628655 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628657 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628658 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628659 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628660 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2314C103EE 00643169780422 V30628737 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628738 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628739 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628740 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628741 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628742 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628743 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628744 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628745 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628746 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628747 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628748 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628750 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628751 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628752 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628753 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628754 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103E 00643169439979 V30629481 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629492 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629493 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629496 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629501 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629503 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629505 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629516 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629517 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629529 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629530 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629531 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629532 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629539 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2814C103EE 00643169780446 V30629760 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629761 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629762 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629763 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629764 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629765 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629766 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629767 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629768 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629770 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629771 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629772 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629773 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF Serial Numbers: V30609409 V30609410 V30609411 V30609412 V30609415 V30609417 V30609420 V30609421 V30609423 V30616743 V30616746 V30616748 V30618898 V30618899 V30618902 V30618963 V30618964 V30618965 V30618966 V30618967 V30618968 V30618969 V30618970 V30618971 V30618972 V30618973 V30618974 V30618975 V30618976 V30618977 V30618978 V30618979 V30618980 V30618982 V30618983 V30618984 V30618988 V30618989 V30619120 V30619159 V30619161 V30625915 V30625916 V30625917 V30625918 V30625921 V30625935 V30625936 V30625938 V30625941 V30625942 V30625943 V30625944 V30625945 V30625946 V30625947 V30625948 V30625949 V30625950 V30625951 V30625952 V30625953 V30625954 V30625957 V30625958 V30625961 V30625962 V30625963 V30625985 V30628576 V30628577 V30628578 V30628579 V30628580 V30628581 V30628582 V30628583 V30628584 V30628585 V30628586 V30628587 V30628588 V30628625 V30628639 V30628643 V30628652 V30628654 V30628655 V30628657 V30628658 V30628659 V30628660 V30628737 V30628738 V30628739 V30628740 V30628741 V30628742 V30628743 V30628744 V30628745 V30628746 V30628747 V30628748 V30628750 V30628751 V30628752 V30628753 V30628754 V30629481 V30629492 V30629493 V30629496 V30629501 V30629503 V30629505 V30629516 V30629517 V30629529 V30629530 V30629531 V30629532 V30629539 V30629760 V30629761 V30629762 V30629763 V30629764 V30629765 V30629766 V30629767 V30629768 V30629770 V30629771 V30629772 V30629773

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 88951

This product is part of a recall event; the main page for the event is Endurant II Stent Graft System recalled by Medtronic Vascular.

Reported	Class	Recall	Company	Reason	Where
1 Dec 2021	CLASS II	Endurant II Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
1 Dec 2021	CLASS II	Endurant Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide

More recalls from Medtronic Vascular

All 227

Reported	Class	Recall	Company	Reason	Where
18 May 2022Device	CLASS II	Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon recalled	Medtronic Vascular	Sterility	Nationwide
18 May 2022Device	CLASS II	Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter recalled	Medtronic Vascular	Sterility	Nationwide
1 Dec 2021Device	CLASS II	Endurant Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
1 Dec 2021Device	CLASS II	Endurant II Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
4 Aug 2021Device	CLASS II	Medtronic Endurant IIs Stent Graft System Medtronic recalled	Medtronic Vascular	Other	8 states

Other Heart & Vascular Devices recalls

All 6,267

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Fathom/027/Straight/1RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/1RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/155 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/J/1RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide