A Bard LifeStent Solo Vascular Stent recall has received a Class I recall designation by the U.S. Food and Drug Administration (FDA). The device may fail to deploy, which may potentially cause serious adverse reactions.
The U.S. Food and Drug Administration (FDA) Class I recall designation means that this is the most serious type of recall and involves situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.
The FDA notified health professionals and medical care organizations of the Class I recall that involves device deployment issues including failure to deploy, partial deployment, and difficult deployment. Use of the recalled Bard’s LifeStent Solo Vascular Stent may lead to serious adverse health consequences that include potential bleeding complications, loss of limb, myocardial infarction (heart attack), stroke, vascular surgery, and/or death.
The LifeStent Solo Vascular Stent is an implantable self-expanding stent and delivery system. The system is used to improve the luminal diameter—the open space—of a blood vessel when treating lesions resulting from the abnormal narrowing in a blood vessel, which is known as symptomatic de-novo or restenotic lesions.
The recalled LifeStent Solo Vascular Stents were manufactured and distributed from November 2011 to June 13, 2012. Product codes and lot numbers for the recalled devices may be accessed here.
On September 30, 2013, Bard Peripheral Vascular issued an “Urgent: Medical Device Recall Notification” letter that advised impacted customers of the product, problem, and actions to be taken. Customers were also instructed to complete the Recall and Effectiveness Check Form, regardless of whether or not they were in possession of the recalled medical device, and to fax the completed form to Bard Peripheral Vascular at 1.800.994.6772. Customers were also advised to call the Bard Peripheral Vascular Recall Coordinator to receive a return authorization or consignment recall number. Bard Peripheral Vascular Inc. can be reached, toll-free, at 1.800.321.4254 (Option #2, Extension 2727), Monday through Friday, 7:00 a.m. to 4:00 p.m. Mountain Standard Time (MST).
Health care professionals and consumers may report adverse reactions or quality problems they experience using these—or any medical device or drug product—to MedWatch: The FDA Safety Information and Adverse Event Reporting Program, which can be accessed here..