Recall Z-0223-2016 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Bard Peripheral Vascular Inc
FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The distal end of the flared confi
| Date | Nov 5, 2015 (initiated Oct 19, 2015) |
| Status | Terminated |
| Reason | Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could occur during use. |
| Root cause | Device Design |
| Action | Bard sent an Urgent Medical Device Recall Notification letter dated October 19, 2015, to customers who received the Bard Flair Endovascular Stent Grant. The letter informs customers that the harm associated with failure to deploy or deployment related issues that could occur during use may pose an incremental risk to the already inherit risk associated with stent graft procedures. The letter also provides customers with the actions to be taken. Customers were instructed to call Bard Peripheral Vascular's (BPV) Recall Coordinator at 1-800-321-4254 Option #2 Ext 2501 (M-F 6am to 3pm MST). Cu |
| Quantity | 292 units |
| Distribution | Nationwide in US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.