# P140016: Zenith Alpha Thoracic Endovascular Graft

- Pathway: PMA
- Applicant: Cook Medical Incorporated
- Decided: Sep 15, 2015 after 398 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- Device class: 3
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 18, 2025 · Class I · Z-0043-2026: Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
- Mar 22, 2017 · Class I · Z-2099-2017: 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 reinterventi

Source page: https://510kreport.com/device/P140016
Methodology: https://510kreport.com/methodology