Cook Medical is recalling several thousand Zenith Alpha graft products, which are designed to treat lesions in the aorta, warning that they could increase the risk of blood clots.
The Zenith Alpha Thoracic Endovascular Graft recall was announced by the FDA on Wednesday, after the manufacturer issued an Urgent Medical Device Correction and Removal notifications. While the notices were issued in March and June, the agency decided this week that the action constitutes a Class I medical device recall, the most serious recall classification, which means the FDA believes the problems with the grafts carry a risk of severe injury or death for patients.
The Zenith Alpha Thoracic Endovascular Graft is used to treat isolated lesions in the aorta, which is the body’s main blood vessel, carrying blood from the heart into the abdomen throughout the body. It is also used to treat blunt thoracic aortic injuries (BTAI), which are often caused by auto accidents and other severe cases of trauma. Unless treated quickly, these types of injuries can result in death.
Cook Medical reports that it has received cases of blood clots and cases where the grafts were blocked or closed, which could result in serious injury or death.
First warnings about the Zenith Alpha aorta graft problems were issued in a notification sent to customers on March 22. An updated notice was issued on June 22, when the manufacturer removed the indication for blunt thoracic aortic injuries. The removal of this use means that specific sizes of the device have to be taken from the market, because they were specifically designed for use in those types of injuries.
The recall affects all serial numbers and all lots of Cook Medical Zenith Alpha Thoracic Endovascular Grafts, manufactured between April 10, 2015 and January 3, 2017. They were distributed between October 29,. 2015 and March 10, 2017.
The company indicates that it intends to relabel about 4,500 devices and to remove 500 devices with diameters between 18 and 22 mm permanently. Customers with questions can contact Cook Medical Customer Relations by calling 800-457-4500 or 812-339-2235.
The FDA is requesting that health care professionals and patients report any adverse reactions linked to these devices to the agency’s MedWatch Adverse Event Reporting Program.