Reported Aug 4, 2021 · Ongoing
Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and…
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?
- 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.
- Lot codes and dates
21 of 21 products
Products covered by this recall Model / number Product as published 00643169439962Model (REF):ESBF3214C103E Serial Numbers: V29780773 — V29780771 — V29780759 00643169780460Model (REF): ESBF3614C103EE Serial Numbers: V29781932 — V29781933 — V29781934 — V29781935 — V29781936 — V29781937 — V29781938 — V29781939 — V29781940 — V29781941 — V29781942 — V29781943 — V29781944 — V29781945 — V29781946 — V29781947 — V29781948 - Amount recalled
- 21 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 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.
This product could cause temporary or reversible health problems — stop using it.
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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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