Recall Z-2099-2017 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Cook Medical Incorporated
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: " Iliac/femoral anatomy that is suitable for access with the required introduction systems, " Nonaneury
| Date | Aug 10, 2017 (initiated Mar 22, 2017) |
| Status | Terminated |
| Reason | There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention. |
| Root cause | Device Design |
| Action | The firm, Cook Medical, sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 22, 2017 to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. On 6/22/2017, updated "URGENT: MEDICAL DEVICE CORRECTION AND REMOVAL" notifications were sent to the affected consignees via courier. The update included removal of the indication for use in BTAI, as follows: The Zenith Alpha Thoracic Endovascular Graft is ind |
| Quantity | 4916 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.