Reported Jul 15, 2020 · Terminated
Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular…
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
- Catalog Prefix ZIMB - Product Usageis indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair
- Lot codes and dates
804 of 804 codes
10225099130866311023649610236495130866281308662913086630101994541019947010248188102481891020553310205533X1026115410262338102623391026234010208616102086171022262110216004102250981023649710241031102425031024250410248190130866331020861910208618102157701022262210236499102364981024250510258804102651091305962013090275102389091024588010248214102503621309816410250364102503611026234510262346102694831025036310222636130598661023356310291651102364291023891010238912102389131023891410238916
- Amount recalled
- 571
Why it was recalled
Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard 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.
Free recall alerts
Get alerted about new Cook Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.