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Terminated

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.

FDA Recall Z-0007-2014 · Posted 2013-10-10

Recall StatusTerminated
Product CodeNIP
Date Initiated2013-09-30
Date Terminated2014-02-05
Product Quantity4112 units

Reason for Recall

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.

Firm 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 [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.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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