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FDA Slaps Class I Recall on C.R. Bard's LifeStent Solo Vascular Stent

10/21/2013 7:58:31 AM

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Bard LifeStent Solo Vascular Stent - Failure to Deploy Stent

Recall Class: Class I

Date Recall Initiated: September 30, 2013

Product: LifeStent Solo Vascular Stent

Product Codes/Lot Numbers

To locate product codes and lot numbers of affected products, refer to FDA’s Class I Recall information under “Additional Links” below.

The affected products were manufactured and distributed from November 2011 to June 13, 2012.

Use: The LifeStent Solo Vascular Stent is an implantable self-expanding stent and delivery system used to improve the inner open space of a blood vessel (luminal diameter) in the treatment of lesions caused by the abnormal narrowing in a blood vessel (symptomatic de-novo or restenotic lesions).

Recalling Firm:

Bard Peripheral Vascular Inc.

1625 W 3rd St Ste 109

Tempe, Arizona 85281

Reason for Recall:

The deployment mechanism for the affected LifeStent Solo Vascular Stents may not perform properly when used. Deployment issues range from failure to deploy, partial deployment, and difficult deployment. This product may cause serious adverse health consequences, including possible complications of bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death.

Public Contact: For questions about this recall, contact Bard Peripheral Vascular Inc. at 1-800-321-4254 (Option #2, Extension 2727) Monday through Friday, 7 am to 4 pm Mountain Standard Time.

FDA District: Los Angeles District Office

FDA Comments:

On September 30, 2013, Bard Peripheral Vascular sent an “Urgent: Medical Device Recall Notification” letter informing affected customers of the product, problem, and actions to be taken. Customers were instructed to do the following:

Complete the Recall and Effectiveness Check Form (even if you no longer have the recalled product) and fax form to Bard Peripheral Vascular at 1-800-994-6772

Call Bard Peripheral Vascular’s Recall Coordinator to receive a Return Authorization Number or Consignment Recall Number

The Bard Peripheral Vascular Recall Coordinator can be reached at 1-800-321-4254, Ext. 2727 (M-F, 7 am to 4 pm MST) or by email at Bard Peripheral Vascular will provide replacement products for returned products.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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