FDA product code MIH: System, Endovascular Graft, Aortic Aneurysm Treatment
MIH is the FDA product code for system, endovascular graft, aortic aneurysm treatment. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MIH reach the market by PMA; FDA lists no cleared 510(k)s for it. 21 PMA applications cite this product code. FDA has posted 176 recalls for MIH devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MIH devices
176 product recalls in 44 recall events; 11 initiated in the last five years and 15 still open. Most recent: 2026-05-19.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 8 |
| 2021 | 8 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code MIH?
MIH is the FDA product code for system, endovascular graft, aortic aneurysm treatment. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MIH?
Class III. Typical premarket route: PMA.
Have MIH devices been recalled?
Yes: 176 product recalls across 44 recall events; the most recent began 2026-05-19.
Next steps
- Run an FDA pathway report with predicate devices for product code MIH
- Run a recall and safety report across every MIH manufacturer
- Watch product code MIH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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