Reported Sep 23, 2020 · Terminated
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients…
Cook 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: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac
- aneurysms Reference Part Number (RPN)
ZIMB-22-108ZIMB-22-118ZIMB-22-128ZIMB-22-70ZIMB-22-84ZIMB-22-98ZIMB-24-108ZIMB-24-118ZIMB-24-128ZIMB-24-70ZIMB-24-84ZIMB-24-98ZIMB-26-108ZIMB-26-118ZIMB-26-128ZIMB-26-70ZIMB-26-84ZIMB-26-98ZIMB-28-108ZIMB-28-118ZIMB-28-128ZIMB-28-70ZIMB-28-84ZIMB-28-98ZIMB-30-108ZIMB-30-118ZIMB-30-128ZIMB-30-70ZIMB-30-84ZIMB-30-98ZIMB-32-108ZIMB-32-108ZIMB-32-118ZIMB-32-128ZIMB-32-70ZIMB-32-84ZIMB-32-98ZIMB-36-108ZIMB-36-118ZIMB-36-128ZIMB-36-84ZIMB-36-98
- Lot codes and dates
- Reference Part / Lot Numbers
673 of 673 codes
ZIMB-22-108 91821419983461100107901013664913023971ZIMB-22-118 10077065ZIMB-22-70 91709489196501919650293115029415647101565461027523910337923ZIMB-22-84 9100087910008991181609124830913242391821459403140941563694156379964029996405599747989974799101539641015396510337925ZIMB-22-98 9108371916390294067861013663110275243ZIMB-24-108 93383019854089993672099367229939734993973699457499945751994575310318498ZIMB-24-118 9100111916385399592529995361999938610275245ZIMB-24-128 9136557ZIMB-24-70 90844999118179911818091638599184781919648791965909300915
- Reference Part / Lot Numbers
- Amount recalled
- 684 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU
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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