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Product Liability – Defective Medical Device: FDA initiates Class 1 recall of some Bard LifeStent Solo Vascular Stents because they may fail to deploy
The defective stents may cause serious personal injury such as complications of bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death if they fail to deploy properly.
The LifeStent Solo Vascular Stent manufactured by Bard Peripheral Vascular is an implantable self-expanding stent and delivery system used to improve the inner open space of a blood vessel in patients who have lesions caused by abnormal narrowing of the affected blood vessel.
Defective products were manufactured and distributed from November 2011 to June 13, 2012 , the defective implants code information can be found on the FDA website