11.28.13
C.R. Bard Inc. is recalling one of its self-expanding vascular stents because the mechanism used to implant the device into patients potentially can malfunction. The U.S. Food and Drug Administration (FDA) has branded the recall a Class I action--its most serious designation.
Bard initiated the recall of its 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 cannot easily be 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.
"Deployment issues range from failure to deploy, partial deployment, and difficult deployment," the FDA's recall notice reads. "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."
Bard's Peripheral Vascular Division issued its recall notification on Sept. 30, and the Murray Hill, N.J., 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 initiated the recall of its 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 cannot easily be 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.
"Deployment issues range from failure to deploy, partial deployment, and difficult deployment," the FDA's recall notice reads. "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."
Bard's Peripheral Vascular Division issued its recall notification on Sept. 30, and the Murray Hill, N.J., 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.