Recall: Bard LifeStent Solo Vascular Stent

The FDA has issued a Class I recall of the LifeStent Solo Vascular Stent manufactured by Bard Peripheral Vascular Inc.  Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.  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 recall is being issued because the stent's deployment mechanism may not perform properly when used.  Deployment issues range from failure to deploy, partial deployment, and difficult deployment.  These issues may cause serious adverse health consequences, including possible complications of bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death.

[1] FDA Medical Device Recall "Bard LifeStent Solo Vascular Stent - Failure to Deploy Stent" (September 30, 2013).