Endovascular grafts recalled due to risk of coating breaking off, entering bloodstream
Cook Medical, an Indiana-based medtech company, has recalled certain endovascular grafts due to a risk of tiny pieces of polytetrafluoroethylene breaking off and entering the patient’s bloodstream. The recall covers nearly 700 Zenith Alpha 2 Thoracic Endovascular Graft proximal components, including devices with diameters of 40 mm, 42 mm, 44 mm, and 46 mm.
The U.S. Food and Drug Administration (FDA) has ruled that this is a Class I recall. This means using the devices is associated with an increased risk of serious injury or death.
“The use of affected product may cause serious adverse health consequences, including injury from fragments entering the bloodstream (embolization) such as stroke and death,” according to the FDA’s advisory.
Cook Medical has not received reports of any serious injuries or deaths that are associated with this issue.
Additional details about this Class I recall
Cook Medical’s Zenith Alpha 2 Thoracic Endovascular Graft is used to treat aneurysms or ulcers of the descending thoracic aorta before catheter-based procedures. While this recall dates from September, the FDA only announced it to the public on Dec. 23.
Customers are urged to examine their inventory immediately, quarantine any unused products and return them to the manufacturer. These devices are being removed from the market, and the company has said an investigation is being opened to explore what can be done to prevent similar issues in the future.
The polytetrafluoroethylene coating at the center of this recall is most commonly known as Teflon. Click here for additional information about the use of polytetrafluoroethylene and other per- and polyfluoroalkyl substances in the medtech industry.
A full list of the devices include in this recall is available here.
Back in June, Cook Medical recalled certain angiographic catheters due to an increased risk of the tip becoming separated from the rest of the device during treatment.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.