Reported Dec 1, 2021 · Ongoing
Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE…
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 Stent Graft System REF/DescriptionETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETBF2313C166EE STENT GRAFT ETBF2313C166EE ENDUR II BIF ETBF2513C124EE STENT GRAFT ETBF2513C124EE ENDUR II BIF ET
- Lot codes and dates
375 of 375 products
Products covered by this recall Model / number Barcodes Product as published ETBF2513C145EE00643169781047V30584649 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE00643169781177V30593589 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE00643169781177V30593590 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE00643169781177V30593591 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE00643169781177V30593592 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE00643169781177V30593593 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE00643169781177V30593594 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE00643169781177V30593595 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE00643169780798V30595328 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE00643169780798V30595331 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE00643169780798V30595332 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE00643169780934V30595382 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE00643169780934V30595383 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE00643169780934V30595386 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE00643169780934V30595389 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE00643169780934V30595390 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE00643169780934V30595391 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE00643169780972V30595456 STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE00643169781047V30595505 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE00643169781047V30595515 STENT GRAFT ETBF2513C145EE ENDUR II BIF - Amount recalled
- 511 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
Due to, 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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