Cook Medical Recalls Zenith Alpha Grafts Over Thrombosis Fears
Cook Medical recalled its Zenith Alpha endovascular graft because of the potential for clotting.
The device is intended for treatment of isolated lesions in the descending thoracic aorta. The recall applies to all lots manufactured between April 10, 2015 and January 3, 2017, or distributed between October 29, 2015 and March 10, 2017.
Cook Medical announced the recall after becoming aware of cases where blood clots formed inside the device after implantation. Blockage or closure of the graft could lead to serious adverse events.