Cook Medical Issues Recall Correction of Zenith Alpha ™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market

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. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase.
Source: Food and Drug Administration - Category: Food Science Source Type: news