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Bard LifeStent Solo Vascular Stent: Class 1 Recall - Failure to Deploy
AUDIENCE: Cardio-vascular Surgery, Interventional Radiology
ISSUE: FDA notified health professionals and medical care organizations of a class 1 recall of this product due to deployment issues that 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.
BACKGROUND: 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). The affected products were manufactured and distributed from November 2011 to June 13, 2012. To locate product codes and lot numbers of affected products, refer to FDA’s Class I Recall information under “Additional Links”.
RECOMMENDATIONS: 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 (1) 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, and (2) Call Bard Peripheral Vascular’s Recall Coordinator to receive a Return Authorization Number or Consignment Recall Number.
Bard Peripheral Vascular Inc. can be contacted at 1-800-321-4254 (Option #2, Extension 2727) Monday through Friday, 7 am to 4 pm MST.
Read the MedWatch safety alert, including a link to the Class I recall notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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