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U.S. Department of Health and Human Services

Class 1 Device Recall LifeStent Solo Vascular Stent

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 Class 1 Device Recall LifeStent Solo Vascular Stent see related information
Date Posted October 10, 2013
Recall Status1 Terminated on February 05, 2014
Recall Number Z-0007-2014
Recall Event ID 66374
PMA Number P070014S032 
Product Classification Stent, superficial femoral artery - Product Code NIP
Product 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.
Code Information 84 ANVH1464 ANVI2299 ANVK1979 ANVL1603 ANWA0496 ANWF0371 ANVH1465 ANVI2300 ANVK1980 ANVL2035 ANWA0497 ANWF0716 ANVH1466 ANVI2301 ANVK1981 ANVL2036 ANWA0498 ANWF0717 ANVH1620 ANVI2515 ANVK2222 ANVL2037 ANWA0705 ANWF0983 ANVH1621 ANVJ0567 ANVK2433 ANVL2348 ANWA0706 ANWF0985
Recalling Firm/
Manufacturer
Bard Peripheral Vascular Inc
1625 W 3rd St Ste 109
Tempe AZ 85281-2438
480-894-9515
For Additional Information Contact
480-894-9515
Manufacturer 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.
FDA Determined
Cause 2
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.com. 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.
Quantity in Commerce 4112 units
Distribution US Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIP and Original Applicant = BARD PERIPHERAL VASCULAR, INC.
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