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Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft
The FDA is aware that Cook Medical has issued a letter to affected customers recommending certain Zenith Alpha 2 Thoracic Endovascular Graft proximal components be removed from where they are used or sold.
Cook Medical is recalling certain Zenith Alpha 2 Thoracic Endovascular Graft proximal components (tapered and non-tapered configurations) 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 40 mm and 46 mm.
The use of affected product may cause serious adverse health consequences, including injury from fragments entering the bloodstream (embolization) such as stroke and death.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.
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