Bard LifeStent Recall Deemed Class I Due to Deployment IssuesOct 24, 2013
Bard’s LifeStent Solo Vascular Stent recently received the U.S. Food and Drug Administration (FDA) Class I recall designation due to the device’s failure to deploy.
Class I recalls are the most serious; in recalls deemed Class I there is generally a reasonable probability that use of the product in question will cause serious adverse health consequences or death.
The agency advised health professionals and medical care organizations of the recall, which centers on deployment issues, such as failure to deploy, partial deployment, and difficult deployment. Use of the recalled Bard’s LifeStent Solo Vascular Stent may lead to serious adverse health consequences, including possible complications resulting from bleeding, loss of limb, myocardial infarction (heart attack), stroke, vascular surgery, and/or death.
The LifeStent Solo Vascular Stent is an implantable self-expanding stent and delivery system used to improve the luminal diameter, or inner open space, of a blood vessel when treating lesions caused by the abnormal narrowing in a blood vessel known as symptomatic de-novo or restenotic lesions.
The recalled LifeStent Solo Vascular Stents were manufactured and distributed from November 2011 to June 13, 2012. Specific product codes and lot numbers for the recalled devices may be accessed at: