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FDA Issues Recall Notice about LifeStent Solo Vascular Stent

FDA Issues Recall Notice about LifeStent Solo Vascular Stent

The FDA recently warned of a recall affecting LifeStent Solo Vascular Stent distributed between November 2011 and June 2012. The maker of this defective medical device, Bard Peripheral Vascular Inc., recalled the device and issued an Urgent Medical Device Recall Notification to its customers.

The device "is an implantable... stent and delivery system used to improve the inner open space of a blood vessel... in the treatment of lesions caused by the abnormal narrowing in a blood vessel..." Issues affecting the deployment mechanism of LifeStent Solo Vascular Stent may cause serious health complications that include "bleeding, loss of limb, heart attack... stroke, vascular surgery, and/or death." Due to the potential for such grave health consequences, the device recall was "Class I" - the most serious type of recall.

Sources:

FDA,

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm371318.htm

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371415.htm

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