Healthcare providers and clinical teams should be aware that the FDA has classified a recall of Cook Medical's Zenith Alpha 2 Thoracic Endovascular Graft proximal components as the most serious type of medical device recall. The recall, initiated on September 18, 2025, was prompted by findings that these components may release fragments of polytetrafluoroethylene (PTFE) coating into the bloodstream during use, posing potential serious health risks such as stroke or death.
What changed?
Cook Medical has announced the immediate recall of specific Zenith Alpha 2 Thoracic Endovascular Graft proximal components. Impacted products include tapered and non-tapered configurations of the graft with diameters of 40 mm, 42 mm, 44 mm, and 46 mm. The recall spans all length ZTA2-P/PT devices within these diameter specifications. The FDA underscores that continued use of these grafts could result in severe adverse events, including embolization due to PTFE fragments, leading to injury, stroke, or potentially fatal complications.
As of September 10, Cook Medical reported to the FDA that no injuries or deaths had been associated with this issue. However, the urgency of the recall emphasizes the potential risks involved.
What is the device used for?
The Zenith Alpha 2 Thoracic Endovascular Graft is a specialized medical device for treating bulges (aneurysms) or ulcers in the descending thoracic aorta—the longest part of the aorta. The system is used in patients eligible for an endovascular approach, which involves inserting a catheter through blood vessels to deliver treatment precisely.
Actions for healthcare providers
Identify and quarantine affected products
Healthcare institutions must check their inventory immediately for any affected Zenith Alpha 2 components. All distribution or use of these devices must cease. Any unused products should be quarantined to prevent further application.
Follow Cook Medical's recommendations
In the urgent recall letter distributed to customers on September 18, Cook Medical outlined the following steps:
- Stop all use and distribution of the affected products.
- Quarantine and return any affected devices to Cook Medical.
- Share this notification with relevant staff within the organization or other locations where affected devices have been transferred.
The manufacturer has also launched an internal investigation to determine corrective measures to prevent similar issues in the future.
Safety and reporting
The FDA highlights the value of the Unique Device Identifier (UDI) system in tracking medical devices throughout their lifecycle. By using the UDI, healthcare providers and consumers can better identify affected devices and report adverse events more efficiently. Adverse reactions or quality issues related to these components should be reported through the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Conclusion
The recall of the Zenith Alpha 2 Thoracic Endovascular Graft highlights the critical role of medical device safety. Immediate action from healthcare providers is necessary to mitigate risks and ensure patient safety. For a full understanding of this recall and affected product details, clinical teams should consult the FDA and Cook Medical directly. Ensuring compliance with recall procedures is key to maintaining trust and safety in medical treatments.
Disclaimer
This article is intended for informational purposes for clinical, quality, and regulatory teams. It does not constitute legal advice or professional guidance. For specific recommendations, consult relevant authorities and healthcare regulations.
Mandatory FDA Information
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/endovascular-graft-recall-cook-medical-removes-zenith-alpha-2-thoracic-endovascular-graft