# FDA recall Z-2099-2017

> **Cook Medical Incorporated** · Class I · device recall initiated 2017-03-22.

## 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.

## Distribution

Nationwide Distribution.

## Key facts

- **Recall number:** Z-2099-2017
- **Recalling firm:** Cook Medical Incorporated
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-03-22
- **Report date:** 2017-08-16
- **Termination date:** 2019-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2099-2017

## Citation

> AI Analytics. FDA recall Z-2099-2017. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-2099-2017. Source: US FDA. Licensed CC0.

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