Cook Medical Inc. recalled its Zenith Alpha Thoracic Endovascular Graft for the treatment of blunt traumatic aortic injury due to the potential for blood clots to form inside the device after it has been implanted.
An implantable device used to treat injuries in a patient's main blood vessel is being recalled due to the potential for blood clots to form inside the device.
|Cook Medical Inc. recalled all lots of its Zenith Alpha Thoracic Endovascular Graft.|
Cook Medical Inc. recalled all lots of its Zenith Alpha Thoracic Endovascular Graft for the treatment of blunt traumatic aortic injury (BTAI). The recalled devices were made between April 10, 2015 and Jan. 3, 2017, and distributed between Oct. 29, 2015 and March 10, 2017.
Cook said there have been reported cases where the graft became blocked or closed when used to treat a blunt traumatic aortic injury (BTAI). When this happens, it can lead to serious adverse health consequences, including death.
Cook initiated the recall on March 22, and FDA classified it as a Class I recall this week. The company sent an updated recall notice to customers on June 22 to inform them that the instructions for use for the device had been updated to remove the indication for use in BTAI.
This means roughly 4,500 devices will be relabeled, and about 500 devices will be removed from the market. It does not mean that the devices should be removed from patients, Cook told Qmed.
FDA approved the Zenith Alpha Thoracic Endovascular Graft in September 2015.
[Image credit: FDA]