PMA · Approved
Recalled · Class I · 2025Zenith Alpha Thoracic Endovascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Medical Incorporated · MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Approved on Sep 15, 2015 through premarket approval, which rests on the device’s own clinical evidence after a 398-day review. It has a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Sep 15, 2015
- Review
- 398 days
- Class
- Class III
- Product code
- MIH
- Recalls
- 2 (2 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P140016 has 18 supplements since 2017: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2017 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 4 |
| 2025 | 2 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2025 | Class I | Z-0043-2026 | Process design | 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 | Device Design | 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. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MIH devicesMIH System, Endovascular Graft, Aortic Aneurysm Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MIH
50in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MIH
Too few MIH 510(k)s in any year since 2007 to give a median.
Recalls per year · MIH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · MIH
3,302in 2025
MAUDE reports naming product code MIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 33 | — | 1 | 1,323 |
| 2008 | 45 | — | 0 | 1,745 |
| 2009 | 49 | — | 0 | 2,600 |
| 2010 | 46 | — | 0 | 2,493 |
| 2011 | 64 | — | 29 | 3,241 |
| 2012 | 57 | — | 3 | 3,787 |
| 2013 | 48 | — | 0 | 3,883 |
| 2014 | 80 | — | 1 (1) | 4,249 |
| 2015 | 53 | — | 1 | 4,471 |
| 2016 | 47 | — | 6 | 4,296 |
| 2017 | 41 | — | 3 | 4,105 |
| 2018 | 39 | — | 4 (4) | 4,178 |
| 2019 | 34 | — | 0 | 3,592 |
| 2020 | 44 | — | 4 | 3,057 |
| 2021 | 50 | — | 4 | 3,686 |
| 2022 | 49 | — | 2 | 3,455 |
| 2023 | 50 | — | 0 | 3,562 |
| 2024 | 62 | — | 0 | 3,320 |
| 2025 | 50 | — | 1 (1) | 3,302 |
| 2026 | 35 | — | 2 (1) | — |
https://510kreport.com/device/P140016 · printed Nov 6, 2026
Cite this page
510(k) Report. “P140016: Zenith Alpha Thoracic Endovascular Graft.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P140016
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026