Deployment Problems Lead to FDA Recall for Bard’s LifeStent Solo Vascular Stent

The FDA has issued a Class I recall notice on certain product codes and lot numbers of Bard’s LifeStent Solo Vascular Stent, manufactured between November 2011 and June 2012. The reason for the recall is a potential failure to deploy the stent, which would have potentially serious adverse health consequences.

Background

The LifeStent Solo Vascular Stent is an implantable self-expanding stent and delivery system used to improve a peripheral blood vessel’s luminal diameter in the treatment of lesions caused by the abnormal narrowing in a blood vessel.

The reason for this recall is that it seems the deployment mechanism for the affected devices may not perform properly when used. This may mean a failure to deploy, partial deployment, or just difficult deployment.

When this happens the FDA has concluded it may result in serious adverse health consequences, including possible complications of bleeding, loss of limb, myocardial infarction, stroke, vascular surgery, and/or death. As such the agency has issued its highest classification of recall, a Class I.

Customers have already been contacted by Bard in a notification which included instructions to contact the company in order to return goods identified as at risk.

The full list pf products included in the recall can be found, together with additional information, on the FDA’s recall notice, here.