Recall Z-0310-2007 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Endologix Inc
Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL
| Date | Dec 27, 2006 (initiated Nov 8, 2006) |
| Status | Terminated |
| Reason | Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair. |
| Root cause | Other |
| Action | The affected hospitals were contacted telephone on 11/08/06 and in writing (Recall Letters) sent via FedEx 11/09/06. The firm also released a press statement on 11/10/06. All affected consignees have been contacted and instructed to return the specified products to Endologix. |
| Quantity | 19 |
| Distribution | Worldwide, including USA and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.