The implantable device may not deploy properly. The U.S. Food and Drug Administration (FDA) has announced that Bard Peripheral Vascular Inc. has recalled lots of its LifeStent Solo Vascular Stent because the implantable device may not deploy properly and may cause serious adverse health consequences.
A Class I recall is the FDA’s most serious recall class. Such recalls “involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The deployment mechanism for the affected LifeStent Solo Vascular stents—used to open narrowed blood vessels—may not perform properly when used. Deployment issues range from failure to deploy, partial deployment, and difficult deployment. The affected stents may cause serious consequences, including bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death.
An Urgent Medical Device Recall Notification.
On September 30, 2013, Bard Peripheral Vascular sent an Urgent Medical Device Recall Notification letter informing customers of the problem and the actions that needed to be taken. The recall involves item numbers EX062001CL, EX072001CL, EX062003CL, and EX072003CL. A full list of recalled stents is contained in the recall notice on the FDA website.The affected stents were manufactured and distributed from November 2011 to June 2012.
Those with questions about the recall may contact Bard Peripheral Vascular Inc. at 1.800.321.4254 (Option #2, Extension 2727) Monday through Friday, 7 a.m. to 4 p.m. Mountain Standard Time.
Health care professionals and consumers may report adverse reactions or quality problems with the stents through the FDA’s MedWatch Adverse Event Reporting Program, www.fda.gov/medwatch/report.htm.