CLASS II Device recall · Reported 7 Jul 2021 · FDA Enforcement Report

Endurant II/IIs Stent Graft System recalled by Medtronic Vascular

Medtronic Vascular is recalling Endurant II/IIs Stent Graft System: Stent Graft ETBF3216C145E Endur II Bif, distributed nationwide in the US. The recall was initiated on 28 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;

Quantity recalled3 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-1976-2021
FDA event ID: 88028
Recalling firm: Medtronic Vascular, Santa Rosa, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 Apr 2021
FDA classified: 28 Jun 2021
Reported: 7 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

28 Apr 2021	Recall initiated by company
28 Jun 2021	Classified by FDA	+61 days
7 Jul 2021	Published in enforcement report	+9 days

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

Reason for recall

Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.

Product as listed by the FDA

Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

Where it was distributed

U.S. Nationwide distribution in the state of GA. O.U.S.: None

Nationwide Georgia

Questions about this recall

Why was it recalled?

Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.

Which lots are affected?

Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;

Where was it sold?

U.S. Nationwide distribution in the state of GA. O.U.S.: None

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.

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1 Dec 2021Device	CLASS II	Endurant IIs Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	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

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