Cook Medical Issues Recall Correction to IFU for Zenith Alpha Thoracic Graft, Removing BTAI Indication
August 25, 2017—Cook Medical advised that on June 22, 2017, the company initiated a correction to the instructions for use (IFU) for its Zenith Alpha thoracic endovascular graft. This correction removed the indication for blunt thoracic aortic injury (BTAI; or “transection” of the aorta) because Cook has received an increase in reports of graft thrombosis and occlusion with these devices specifically in the treatment of BTAI.
Cook also initiated a voluntary recall of Zenith Alpha thoracic products for sizes 18 to 22 mm, including the 26- to 22-mm tapered device. These specific sizes are primarily used for BTAI and are no longer available for purchase.
Cook Medical has notified its customers and distributors by Medical Device Correction and Removal letters. All customers and distributors were informed to follow the IFU corrections, quarantine and discontinue use of the recalled sizes, and return the affected product to Cook as soon as possible for credit. A full list of affected products is available on the company's website on the company's website. Products can be identified by the part number on the outer label of the package.
Products in this recall were distributed globally. The US Food and Drug Administration (FDA) and other regulatory agencies around the world have been notified of of the recall action, and the FDA's notification of a class I recall is available on the agency's website here.
Further information for submitting questions or reporting adverse reactions can be found in the company's announcement.