Reported Aug 4, 2021 · Ongoing
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE,…
Medtronic Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular, Inc. · 3850 Brickway Blvd · Santa Rosa, CA · 95403-8223
Is this the product you have?
- Endurant
- II/Endurant IIs Stent Graft SystemMedtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Product as published 00763000099626Model (REF): ETCF3636C49EE Serial Numbers: V29778214 — V29778215 00643169780958Model (REF): ETUF3214C102EE Serial Numbers: V29775791 — V29775792 — V29775793 — V29775794 — V29775795 00763000099626Model (REF): ETBF3216C166EE Serial Numbers: V29778214 — V29778215 00643169232631Model (REF): ETUF3614C102E Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882 - Amount recalled
- 18 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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