Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Zenith Alpha 2 Thoracic Endovascular Graft Recalled by Cook Medical Incorporated Due to Affected devices may contain PTFE coating scrapings. Scrapings...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cook Medical Incorporated directly.
Affected Products
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
Quantity: 695
Why Was This Recalled?
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Where Was This Sold?
This product was distributed to 31 states: AL, AZ, AR, CA, CT, DE, FL, GA, IL, IN, LA, MD, MA, MI, MN, MO, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, DC
About Cook Medical Incorporated
Cook Medical Incorporated has 53 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report