Cook said to be recalling this device because of blood clots that can form within the graft after implantation.
Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall – Potential Formation of Thrombus Inside Device
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. 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.
- Lot or serial numbers: All lots
- Manufacturing dates: April 10, 2015 to January 3, 2017
- Distribution dates: October 29, 2015 to March 10, 2017
- Devices recalled in the U.S.: Approximately 4,500 devices will be relabeled and 500 devices (18 to 22 mm) will be removed.
Please see full recall at FDA.gov
