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 6.5 mm.
Recall
- Recall Number
- Z-0007-2014
- Event Number
- 66374
- Firm
- Bard Peripheral Vascular Inc
- FEI Number
- 2020394
- Product Code
- NIP
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 30, 2013
- Posted
- October 10, 2013
- Terminated
- February 5, 2014
- Address
- 1625 W 3rd St, Ste 109, Tempe, AZ, 85281-2438
Description
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 6.5 mm.
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.
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 [email protected]. The Recall Coordinator will issue you either a Return Authorization (RCL) Number or Consignment Recall Number (CRC) to facilitate the expedient return of the product; and to return the product to Bard Peripheral Vascular, Inc.,1415 W. 3rd Street,Tempe, AZ 85281. BPV will provide replacement product for your returned product. If you have any questions, call 1-800-321-4254 Option #2 Ext. 2727.
US Nationwide Distribution.
4112 units