Cook Medical recalls select Zenith Alpha endo grafts

The FDA today released information on a recall of Cook Medical’s Zenith Alpha thoracic endovascular graft designed for treating blunt traumatic aortic injury over issues with thrombus formation, classifying the recall as Class I. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Zenith Alpha thoracic endovascular graft is designed to treat isolated lesions in main blood vessels that carry blood from the heart through the chest into the abdomen, and is used in patients who have suitable vascular anatomy for endovascular repairs, according to the FDA recall notice. Cook Medical said it is recalling the devices after discovering that blood clots can form inside the device after implantation. The company said it has also received reports of cases where the graft becomes blocked or closed when used to treat BTAI. The company warned that thrombosis or occlusion could lead to serious adverse health consequences, including death. The recall affects approximately 4,500 devices which are slated to be relabeled, while 500 devices will be removed. Units with all existing lot numbers are affected by the recall, manufactured between April 10, 2015 and Jan. 3, 2017 and distributed between Oct. 29, 2015 and March 10, 2017. Cook Medical said it sent an urgent notification to affected customers including updated instructions for use for ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Recalls Vascular Cook Medical Source Type: news