The U.S. Food and Drug Administration (FDA) just announced what it deemed a Class I recall. According to the FDA, the Bard LifeStent Solo Vascular Stent is being recalled over its failure to deploy.
Bard Peripheral Vascular Inc. issued the recall. The FDA deemed the action a Class I, its most serious designation and one that involves situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.The recalled Bard LifeStent Solo Vascular Stents were manufactured and distributed from November 2011 to June 13, 2012. Specific details on product and lot numbers may be accessed here. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122212
The LifeStent Solo Vascular Stent is an implantable self-expanding stent and delivery system that is used to improve the inner open space of a blood vessel—its luminal diameter—in the treatment of lesions caused by the abnormal narrowing in a blood vessel, known as symptomatic de-novo or restenotic lesions.
The deployment mechanism for the recalled LifeStent Solo Vascular Stents may not perform properly when used, with deployment issues that range from failure to deploy, partial deployment, and difficult deployment. This product may cause serious adverse health consequences, including possible complications associated with bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death.
On September 30, 2013, Bard Peripheral Vascular sent an “Urgent: Medical Device Recall Notification” letter informing affected customers of the product, problem, and actions to be taken. Customers were instructed to do:
- Complete the Recall and Effectiveness Check Form (even if they no longer have the recalled product) and fax the form to Bard Peripheral Vascular at 1.800.994.6772
- Call Bard Peripheral Vascular’s Recall Coordinator to receive a Return Authorization Number or Consignment Recall Number
The Bard Peripheral Vascular Recall Coordinator can be reached at 1.800.321.4254, Ext. 2727, Monday through Friday, 7:00 .m. to 4:00 p.m., Mountain Standard Time (MST), or by email at email@example.com.
Bard Peripheral Vascular will provide replacement products for returned products.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.