Reported Dec 1, 2021 · Ongoing
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
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
- Stent Graft System REF/DescriptionENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
- Lot codes and dates
- Model Number/Product DescriptonENTF2525C70EE/STENT GRAFT
- ENTF2525C70EE ENDURANT TUBE GTIN Code00763000006129
- Serial NumbersV30624638 V30624639
- Amount recalled
- 2 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
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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