Cook Medical recalled 695 Zenith Alpha 2 Thoracic Endovascular Grafts on September 18, 2025. The recall follows reports that PTFE coating scrapings could cause intravascular embolization during deployment. Patients and healthcare providers must stop using the device immediately.
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Medical Incorporated or your healthcare provider for instructions. Notification method: Letter
The recalled devices are identified by Catalog Prefix ZTA2 and Reference Part Numbers including ZTA2-P-40-117-W, ZTA2-P-40-167, and others. They were distributed domestically across 20 states and internationally to countries including Switzerland and Germany.
The devices may contain scrapings from the PTFE coating. These scrapings could be released during deployment, posing a risk of intravascular embolization, which can lead to serious health complications.
The recall is classified as Class I due to the high risk associated with the potential release of scrapings. No specific injury or incident counts have been reported.
Patients and healthcare providers should stop using the devices immediately. Contact Cook Medical Incorporated or your healthcare provider for further instructions.
For more information, visit Cook Medical's website or call their customer service line. Additional recall details are available at the FDA's website.
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