This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
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.
- Product Names: Zenith Alpha 2 Thoracic Endovascular Graft, proximal component (tapered or non-tapered configurations) with diameters of 40mm, 42mm, 44mm, and 46mm. All lengths included.
- Unique Device Identifier (UDI)/Lot/Part Numbers: See full list of affected products.
What to Do
Examine inventory immediately and stop all use and distribution of affected products.
On September 18, 2025, Cook Medical sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
- Examine inventory immediately to determine if affected products are present.
- Immediately stop all distribution and use of the affected products.
- Quarantine any unused affected product.
- Return affected product to Cook Medical.
- Share the notice with appropriate personnel, including users, within the organization or anywhere affected devices have been transferred.
- Cook Medical is removing potentially affected products from the market and an investigation has been opened to determine appropriate corrections to prevent similar issues in the future.
Reason for Recall
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.
As of September 10, Cook Medical has not reported any serious injuries or deaths associated with this issue.
Device Use
The Zenith Alpha 2 Thoracic Endovascular Graft is used to treat bulges (aneurysm) or ulcers in the longest part of the aorta (descending thoracic aorta) when the patient is a candidate for treatment with a catheter that is passed through the blood vessels (endovascular).
Contact Information
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.
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
