Cook Medical Recalls Select Zenith Alpha Thoracic Endovascular 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.

Back to news