Medical Device Safety and Recalls: Cook Medical Inc. Recalls Zenith Alpha Thoracic Endovascular Graft for the treatment of Blunt Traumatic Aortic Injury (BTAI) Due to the Potential Formation of Thrombus Inside the Device After Implantation

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Cook Medical Inc. Recalls Zenith Alpha Thoracic Endovascular Graft for the treatment of Blunt Traumatic Aortic Injury (BTAI) Due to the Potential Formation of Thrombus Inside the Device After Implantation

Cook Medical Inc. is recalling the Zenith Alpha Thoracic Endovascular Graft when used for the treatment of BTAI because blood clots (thrombus) may form inside the device after implantation. Cook Medical is also aware of reported cases where the graft became blocked or closed (occlusion) when used to treat BTAI. Thrombosis or occlusion may lead to serious adverse health consequences, including death.

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