–UPDATE–August 24, 2017
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.
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Practical Risk Management Throughout the Product Life Cycle Conference
November 8–9, 2017
Learn moreCook Medical, Inc. has recalled its Zenith Alpha Thoracic Endovascular Graft when used to treat blunt traumatic aortic injury (BTAI) because there is the potential for blood clots to form inside the graft after it is implanted. There have also been reported cases in which the graft became blocked or occluded when treating BTAI. The Class I recall affects all lots of product manufactured between April 10, 2015 and January 3, 2017, and distributed between October 29, 2015 and March 10, 2017.
The Zenith graft treats isolated lesions in the main blood vessel that delivers blood into the abdomen from the heart and through the chest. Occlusion can lead to a serious adverse health event, including death.
The recall was initiated on March 22 via a correction and removal notification, followed by an updated urgent correction and removal on June 22 in which the instructions for use were updated to remove the device indication for use in BTAI.