Class I — Cook Medical Incorporated
| Recalling firm | COOK MEDICAL |
|---|---|
| Registered facility | COOK MEDICAL LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention. |
| Product | Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: " Iliac/femoral anatomy that is suitable for access with the required introduction systems, " Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: " with a length of at least 20 mm, and " with a diameter measured outer wall to outer wall of no greater than 42 mm an… |
| Quantity | 4916 |
| Distribution | Nationwide Distribution. |
| Initiated | 2017-03-22 |
| Classified | 2017-08-09 |
| Terminated | 2019-02-14 |
| Recall number | Z-2099-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Cook Medical Incorporated (Z-2099-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77099/
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