Recall Z-0523-05 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Cook, Inc.
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-140.
| Date | Feb 3, 2005 (initiated Dec 20, 2004) |
| Status | Terminated |
| Reason | The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft. |
| Root cause | Other |
| Action | Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm. |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.