Recall Z-2964-2020 · MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Cook Inc.
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-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-
| Date | Aug 11, 2020 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | Cook Medical issued Urgent Medical Device Recall Dated 8/11/20 either mailed via courier or emailed to consignees stating reason for recall, health risk and action to take: Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. Note: Unaffected products that |
| Quantity | 684 units |
| Distribution | Foreign Only: Canada SWEDEN AUSTRIA Belgium CZECH REPUBLIC DENMARK ESPA¿A FINLAND France GERMANY GREECE HUNGARY IRELAND ISRAEL Italia Nederland NORWAY POLAND PORTUGAL REUNION SERBIA SLOVENIA SOUTH AFRICA SWEDEN UNITED ARAB EMIRATES UNITED KINGDOM AUSTRALIA Hong Kong JAPAN NEW CALEDONIA New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.