Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vas

FDA device recall Z-0007-2014 · posted 2013-10-10 · Terminated

Recall details

Recalling firm

Bard Peripheral Vascular Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

NIP

Quantity affected

4112 units

Distribution

US Nationwide Distribution.

Date initiated

2013-09-30

Date posted

2013-10-10

Date terminated

2014-02-05

Location

Tempe, AZ