|Bard's LifeStent Solo vascular stent--Courtesy of C.R. Bard|
C.R. Bard ($BCR) is recalling one of its self-expanding vascular stents because the mechanism used to implant it into patients can malfunction. Making matters worse, the FDA slapped the product with a Class I recall status--its most serious designation.
Bard initiated its recall of the LifeStent Solo vascular stent on Sept. 30, according to regulators, affecting products made and distributed from Nov. 2011 through June 13, 2012. Specifically, the FDA said the stent can't be easily deployed in some cases due to potential problems with the implant mechanism. Regulators also noted risks of partial deployment and failure to deploy the stent outright.
A Class I recall means there is risk of serious injury or death, and the FDA said the malfunction carries with it possible complications including bleeding, limb loss, heart attack, stroke, the need for vascular surgery or death.
Bard's Peripheral Vascular Division issued its recall notification on Sept. 30, and the New Jersey devicemaker said it would replace returned stents affected by the issue. As the FDA explains, the LifeStent Solo Vascular Stent is an implantable self-expanding stent and delivery system used to treat lesions caused by the abnormal narrowing of a blood vessel.
Bard could not be reached for comment at presstime.
Bard, meanwhile, is closing in on its $262 million cash bid for Minnesota's Rochester Medical ($ROCM), a maker of urology home-care devices. Rochester Medical will hold a shareholder meeting Nov. 13 to approve the deal.
- read the FDA recall