Cook Medical Recalling Zenith Alpha Thoracic Endovascular Graft for Risk of Blood Clots

WASHINGTON, D.C. — Cook Medical Inc. has initiated a Class I recall of its Zenith Alpha Thoracic Endovascular Graft when used for the treatment of blunt traumatic aortic injury (BTAI), explaining that blood clots may form inside the device after implantation, according to the Food and Drug Administration.

Pursuant to the recall, about 4,500 devices in the United States will be relabeled and 500 devices (18 to 20 mm) will be removed, the Aug. 16 alert says.

“The Zenith Alpha Thoracic Endovascular Graft is intended to treat isolated lesions (not including dissections) in a patient's main blood vessel that …