FDA product code · Cardiovascular
System, Endovascular Graft, Aortic Aneurysm Treatment
21 FDA decisions since 1999. 161 recalls name this code, 7 of them Class I. The most-cited predicate is P040002, named by 1 later device.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MIH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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) | — |
Planning a device in MIH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report