FDA: Class I recall of Zenith Alpha Thoracic Endovascular Graft by Cook Medical

Editor's Note

The Food and Drug Administration (FDA) on August 16 classified the recall by Cook Medical Inc (Bloomington, Indiana) of its Zenith Alpha Thoracic Endovascular Graft as Class I, the most serious.

Cook Medical is aware of reported cases where the graft became blocked or closed with blood clots when used to treat blunt traumatic aortic injury. Thrombosis or occlusion may lead to serious adverse consequences, including death.

The recall affects all lots. Manufacturing dates are April 10, 2015, to January 3, 2017. Distribution dates are October 29, 2015, to March 10, 2017.

Posted 08/16/2017] AUDIENCE: Risk Manager, Cardiology, Surgery, Patient ISSUE: Cook Medical Inc. is recalling the Zenith Alpha Thoracic Endovascular Graft when used for the treatment of Blunt Traumatic Aortic Injury (BTAI) because blood clots (thrombus) may form inside the device after implantation.