FDA Issues Class 1 Recall of Vascular Stent

The FDA issued a class 1 recall of Bard Peripheral Vascular Inc.’s LifeStent Solo Vascular Stent, an implantable self-expanding stent and delivery system, as a result of deployment complications including “failure to deploy, partial deployment, and difficult deployment.” According to the FDA, “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.” Products manufactured and distributed between November 2011 and June 13, 2012 are impacted. Read the full FDA safety alert.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Hemorrhage, Myocardial Infarction, Stents, Stroke

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