October 21, 2013 — Bard Peripheral Vascular has sent an urgent Class I medical device recall notification letter informing customers of the problems of the LifeStent Solo vascular stent and the actions customers should take. The LifeStent Solo vascular stent is an implantable self-expanding stent and delivery system used to improve the superficial femoral artery (SFA) luminal diameter in the treatment of atherosclerotic lesions.
The FDA reported the deployment mechanism for the device 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, stroke, vascular surgery and/or death.
Customers were instructed to do the following:
- Complete the Recall and Effectiveness Check Form (even if they no longer have the recalled product) and fax form to Bard Peripheral Vascular at 1-800-994-6772; and
- Call Bard Peripheral Vascular’s recall coordinator at 1-800-321-4254 to receive a Return Authorization Number or Consignment Recall Number.
For more information: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122212