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

Endurant II/Endurant IIs Stent Graft System recalled

Medtronic Vascular is recalling Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II 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 II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882

Quantity recalled18 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-2135-2021
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 stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

Product as listed by the FDA

Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. 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 stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

Which lots are affected?

Endurant II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882

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

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

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