FDA: Class I Recall for Cook’s Thoracic Endovascular Grafts
The graft should no longer be used to treat blunt traumatic aortic injury given the risk of thrombosis or occlusion, says Cook Medical.
The US Food and Drug Administration (FDA) has classified a recent safety notice issued by Cook Medical affecting their Zenith Alpha thoracic endovascular grafts as a class I recall, the agency announced Wednesday.
The endovascular graft is approved for the treatment of patients with aneurysms or ulcers of the descending thoracic aorta, but will no longer be indicated for the treatment of blunt traumatic aortic injury, a change that spurred the recall.
In all, 5,000 units of the Zenith Alpha thoracic endovascular graft distributed between October 29, 2015, and March 10, 2017, are subject to the recall. Approximately 500 of these are grafts with a proximal or distal diameter of 18 to 22 mm, the sizes that would most likely be used only for blunt traumatic aortic injury. The remaining 4,500 units recalled will be relabeled to reflect the new instructions for using the graft.
In a safety alert issued August 16, 2017, the FDA said the company is aware of situations in which the endovascular graft became blocked or occluded following the treatment of blunt traumatic aortic injury.
“Thrombosis or occlusion may lead to serious adverse health consequences, including death,” according to the FDA.
Cook Medical first issued an urgent “medical devices correction and removal” notification to hospitals in March warning of the problem and detailing the reason for the recall. In June, they issued an updated notification informing hospitals that the endovascular graft’s instructions for use were updated to remove the indication for blunt traumatic aortic injury.
The company has said that a sale representative will follow up with all affected hospitals.
Photo Credit: Cook Medical
US Food and Drug Administration. Zenith Alpha Thoracic Endovascular Graft by Cook Medical: class I recall—potential formation of thrombus inside device. Published on: August 16, 2017. Accessed on: August 16, 2017.