The U.S. Food & Drug Administration has announced a recall of the LifeStent Solo Vascular Stent, a device that is surgically implanted in patients to treat lesions caused by abnormal narrowing of a blood vessel. The stents in question were manufactured between November 2011 and June 2013.
Functioning properly, the device’s deployment mechanism expands to improve the inner open space of the affected vessel. Failures in the LifeStent device include a total failure to deploy, with possible complications that can include bleeding, loss of limb, heart attack, stroke, remedial vascular surgery, or death.
Due to the potential harm posed by the defect, the FDA has designated this a Class I recall, defined as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
If you or someone you know has been implanted with the LifeStent product, please contact the injury attorneys at Sommers Schwartz to discuss your situation any action you need to take.