CLASS II ONGOING Device recall · Reported 4 Aug 2021 · FDA Enforcement Report

Medtronic Endurant IIs Stent Graft System Medtronic recalled

Medtronic Vascular is recalling Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System, distributed in 8 states. The recall was initiated on 7 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesEndurant IIs Stent Graft System: Model (REF):ESBF3214C103E GTIN: 00643169439962 Serial Numbers: V29780773; V29780771; V29780759; Model (REF): ESBF3614C103EE GTIN: 00643169780460 Serial Numbers: V29781932; V29781933; V29781934; V29781935; V29781936; V29781937; V29781938; V29781939; V29781940; V29781941; V29781942; V29781943; V29781944; V29781945; V29781946; V29781947; V29781948; V29781951;

Quantity recalled21 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-2136-2021
FDA event ID: 88158
Recalling firm: Medtronic Vascular, Santa Rosa, CA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Jun 2021
FDA classified: 23 Jul 2021
Reported: 4 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

7 Jun 2021	Recall initiated by company
23 Jul 2021	Classified by FDA	+46 days
4 Aug 2021	Published in enforcement report	+12 days

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

Reason for recall

During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

Product as listed by the FDA

Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

Where it was distributed

U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.

Georgia Massachusetts Maryland New York South Carolina Texas Washington West Virginia

Questions about this recall

Why was it recalled?

During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

Which lots are affected?

Endurant IIs Stent Graft System: Model (REF):ESBF3214C103E GTIN: 00643169439962 Serial Numbers: V29780773; V29780771; V29780759; Model (REF): ESBF3614C103EE GTIN: 00643169780460 Serial Numbers: V29781932; V29781933; V29781934; V29781935; V29781936; V29781937; V29781938; V29781939; V29781940; V29781941; V29781942; V29781943; V29781944; V29781945; V29781946; V29781947; V29781948; V29781951;

Where was it sold?

U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.

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

1 other product · FDA event 88158

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

Reported	Class	Recall	Company	Reason	Where
4 Aug 2021	CLASS II	Endurant II/Endurant IIs Stent Graft System recalled	Medtronic Vascular	Other	8 states

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