Bard LifeStent Solo Vascular Stent: Class 1 Recall
MedSun: Newsletter #89, November 2013
FDA MedWatch Safety Alert
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. On September 30, 2013, the manufacturer sent an “Urgent: Medical Device Recall Notification” letter informing affected customers of the product, problem, and actions to be taken.
Bard LifeStent Solo Vascular Stent: Class 1 Recall. FDA MedWatch Safety Alert. October 18, 2013.