FDA: Cook Medical issues recall correction, removal of certain sizes of Zenith Alpha thoracic endovascular graft

Editor's Note

The Food and Drug Administration (FDA) on August 25 announced a recall correction to the instructions for use by Cook Medical (Bloomington, Indiana) for its Zenith Alpha thoracic endovascular graft.

This correction removed the indication for blunt thoracic aortic injury (BTAI) because Cook has received an increase in reports of thrombosis and occlusion with these grafts specifically in the treatment of BTAI.

The company also initiated a voluntary recall of Zenith Alpha thoracic endovascular grafts in sizes 18-22 mm, including the 26-22 mm tapered graft. These sizes are primarily used for BTAI.

Posted 08/25/2017] AUDIENCE: Cardiology, Surgery, Radiology, Risk Manager ISSUE: Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or "transection" of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI.