C.R. Bard (NYSE:BCR) issued a recall for 7 months’ worth of its LifeStent Solo vascular stents, a move the FDA gave its highest-risk Class I label.
The federal watchdog agency said in a recall memo that issues in the stents’ deployment mechanisms could leave patients with "adverse health consequences, including possible complications of bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death."
Affected LifeStent stents may be susceptible to a range of issues, including difficult deployment, partial deployment or total deployment failure, according to the FDA notice.
The FDA gave the recall, which affects certain lots manufactured from November 2011 to June 2012, its Class I label, a risk category reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
New Jersey-based Bard late last month issued a warning letter to its customers, asking them to fill out a check form and work with the company to arrange for return or consignment of affected devices.