Recall Z-0043-2026 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Cook Medical Incorporated
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
| Date | Oct 10, 2025 (initiated Sep 18, 2025) |
| Status | Open, Classified |
| Reason | Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization. |
| Root cause | Process design |
| Action | On September 18, 2025, the recalling firm sent Urgent Medical Device Recall letters to all affected customers. Customers were instructed to identify and quarantine unused affected product in inventory. Immediately cease all further distribution and use of the affected products. Affected product is to be returned to Cook Medical. |
| Quantity | 695 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.