Recall Z-0594-06 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Endologix Inc
Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
| Date | Mar 22, 2006 (initiated Dec 14, 2005) |
| Status | Terminated |
| Reason | The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected. |
| Root cause | Other |
| Action | The three affected hospitals were contacted telephone and in writing (Recall Letters) sent via FedEx Endologix field personnel are scheduled to remove the product units by 12/16/05. Notices for Phase II of recall to 8 additional consignees for 6 additional models (9 lots) being recalled mailed 12/19-12/22/05. |
| Quantity | 32 (24 already used and 8 currently in distribution) |
| Distribution | For units still in distribution: AZ, DE, KS, PA, & TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.