Recall Z-0007-2014 ยท NIP Stent, Superficial Femoral Artery
Bard Peripheral Vascular Inc
Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 6
| Date | Oct 10, 2013 (initiated Sep 30, 2013) |
| Status | Terminated |
| Reason | Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use. |
| Root cause | Device Design |
| Action | The firm, Bard Peripheral Vascular, sent a "Urgent: Medical Device Recall Notification" letter dated September 30, 2013 via FedEx to all the customers who received the specific lots on recall. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to fill out the Recall and Effectiveness Check Form and fax to: BPV at 1-800-994-6772, even if you no longer have possession of the recalled product; call Bard Peripheral Vascular's Recall Coordinator at (800) 321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email silvia.carrillo@crbard.c |
| Quantity | 4112 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.