Cook Medical has issued a letter to affected customers recommending certain Zenith Alpha 2 thoracic endovascular graft proximal (ZTA2-P/PT) components be removed from where they are used or sold, a medical device recall notice issued by the US Food and Drug Administration FDA advises.
The FDA has identified this recall as the most serious type, stating that the device in question “may cause serious injury or death”. The recall notice advises users to “examine inventory immediately and stop all use and distribution of affected products“.
The FDA notice details that Cook Medical sent all affected customers an Urgent Medical Device Recall letter on 18 September 2025 after finding that scrapings of polytetrafluoroethylene (PTFE) coating from the PTFE-coated nitinol release-wire may be released inside the stent graft during use. Impacted components include all length ZTA2-P/PT devices with diameters between 40mm and 46mm.
“The use of affected product may cause serious adverse health consequences, including injury from fragments entering the bloodstream (embolisation) such as stroke and death”, the notice reads.
The FDA shares that, as of 10 September, Cook Medical has not reported any serious injuries or deaths associated with this issue.
Customers in the USA with questions about this recall are advised to contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.
