Cook Medical Incorporated recalls Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-1

Recalled October 22, 2025 · FDA recall Z-0043-2026 · Cook Medical Incorporated

Hazard

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization. · FDA Class I

Units

695

Sold at

Domestic distribution to AL AR AZ CA CT DC DE FL GA IL IN LA MA MD MI MN MO NC NJ NY OH OR PA SC TN TX UT VA WA WI WV International distribution to Switzerland, Germany, Italy, Poland, and Sweden

Description

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

Product

Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40-36-217-W ZTA2-PT-42-38-173 ZTA2-PT-42-38-173-W ZTA2-PT-42-38-225 ZTA2-PT-42-38-225-W ZTA2-PT-44-40-179 ZTA2-PT-44-40-179-W ZTA2-PT-44-40-233-W ZTA2-PT-46-42-179 ZTA2-PT-46-42-179-W ZTA2-PT-46-42-233 ZTA2-PT-46-42-233-W ZTA2-P-46-233 ZTA2-PT-44-40-233 ZTA2-P-40-217 ZTA2-P-40-117 ZTA2-P-40-167-DEMO ZTA2-P-44-152-W ZTA2-P-40-142 ZTA2-P-44-152 ZTA2-P-40-142-W

Manufacturer(s)

Cook Medical Incorporated

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →