Reported Mar 29, 2017 · Terminated
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E…
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 / Endurant II 23mm and 25mm Bifurcated
- Stent Graft Systems Model Numbers
ETBF2516C145EETBF2516C166EETBF2316C145EETBF2313C145EETBF2513C166EETBF2313C166EETBF2316C166EETBF2313C124EETBF2513C145EETBF2516C124EETBF2316C124EETBF2513C124E
- CardiologyThe Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow within the patient's vasculature
- Lot codes and dates
- Product UPN/GTIN Serial numberV
2,505 of 2,505 codes
00613994992048V0588489600643169215849V0598102600643169215849V0598102700643169215849V0598103000643169215849V0598103100643169215849V0598103200643169215849V0598103300643169215849V0598103400643169215849V0598103500613994992024V0598103900613994992024V0598104000613994992024V0598104400613994992024V0598104500643169215856V0598141500643169215856V0598141600643169215856V0598141700643169215856V0598141800643169215856V0598141900643169215856V0598142000643169215856V0598142100643169215856V0598142200643169215856V0598142300643169215856V0598142400613994991263V0598172100613994991263V0598172200613994991263V0598172300613994991263V0598172400613994991263V0598172500613994991263V0598172600613994991263V05981728
- Product UPN/GTIN Serial number
- Amount recalled
- 3331 devices
Where it was sold
Why it was recalled
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
This product could cause temporary or reversible health problems — stop using it.
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