LifeStent Solo Vascular Stents, manufactured by Bard Peripheral Vascular, Inc., are the subject of a Class I recall. The affected products were manufactured and distributed from November 2011 to June 13, 2012.
The LifeStent Solo Vascular Stent System, an implantable self-expanding stent and delivery system, is intended to improve the inner open space of a blood vessel, known as the luminal diameter, in the treatment of symptomatic de-novo or re-stenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 to 6.5 mm.
The deployment mechanism for the affected LifeStent Solo Vascular Stents may not perform properly when used. Deployment issues 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.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Malpractice and Other Liability Issues (to be published Wednesday, November 6).