Recall Z-1284-2012 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Medtronic Vascular, Inc.
Talent Captivia Stent Graft System - FreeFlow configurations only. Model numbers affected have the following designation: TFXXXXXXXXCP and TBXXXXXXXXCP. Medtronic Inc. Santa Rosa, CA 95403. The Talent Thoracic Stent Graft System is designed to treat thoracic aortic aneurysms using an endovascular approach. When placed within the target lesion, the stent graft provides an alternative conduit for b
| Date | Mar 23, 2012 (initiated Feb 21, 2012) |
| Status | Terminated |
| Reason | Complaints received related to the inability/difficulty to release the proximal (FreeFlow) bare stent using the tip capture mechanism. |
| Root cause | Process design |
| Action | Medtronic, Inc. sent an Urgent Medical Device Safety Information letter dated February 2012, to all affected customers. The letter identified the product, the problem, and the corrective action taken by Medtronic. Medtronic updated the Instructions for Use (IFU) manual. For questions regarding this recall call 707-566-1110. |
| Quantity | 1523 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.