Recall Z-1355-2020 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Cook Inc.
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
| Date | Jan 31, 2020 (initiated Jan 16, 2020) |
| Status | Terminated |
| Reason | The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU pertaining to the prevention of these factors. In addition, the firm has updated the Planning and Sizing Worksheet to include associated information. |
| Root cause | Labeling design |
| Action | On January 14, 2020, the firm notified affected customers via Urgent Medical Device Correction letters/emails. Customers were advised to pay especial attention to several aspects of the Instructions for Use (IFU) which were of key importance when implanting a device. Customers were also provided with an updated Planning and Sizing Worksheet. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. |
| Quantity | 68,241 |
| Distribution | Foreign distribution only. Distributed worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.