Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic… — Class I medical device recall Z-2099-2017
Terminated recall by Cook Medical Incorporated, reported 2017-08-16, distributed nationwide. There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatm
| Recall number | Z-2099-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Medical Incorporated, Bloomington, IN, United States |
| Recall initiated | 2017-03-22 |
| Classified | 2017-08-09 |
| Reported by FDA | 2017-08-16 |
| Terminated | 2019-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 4,916 |
| Reason classes | device malfunction |
| Model numbers | ZTA-D-28-160-W, ZTA-D-28-229-W, ZTA-D-30-160-W, ZTA-D-30-229-W, ZTA-D-32-160-W, ZTA-D-32-229-W, ZTA-D-34-142-W, ZTA-D-34-190-W, ZTA-D-36-142-W, ZTA-D-36-190-W, ZTA-D-38-147-W, ZTA-D-38-197-W, ZTA-D-40-147-W, ZTA-D-40-197-W, ZTA-D-42-152-W, ZTA-D-42-204-W, ZTA-D-44-157-W, ZTA-D-44-211-W, ZTA-D-46-157-W, ZTA-D-46-211-W, ZTA-DE-18-104-W, ZTA-DE-18-148-W, ZTA-DE-20-104-W, ZTA-DE-20-148-W, ZTA-DE-22-104-W and 94 more |
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 and no less than 15 mm.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2099-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.