PMA · Approved
Recalled · Class I · 2020Ovation Abdominal Stent Graft System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endologix, LLC · MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Approved on Oct 5, 2012 through premarket approval, which rests on the device’s own clinical evidence after a 177-day review. It has a Class I recall. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Oct 5, 2012
- Review
- 177 days
- Class
- Class III
- Product code
- MIH
- Recalls
- 3 (2 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P120006 has 38 supplements since 2012: 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 |
|---|---|
| 2012 | 1 |
| 2013 | 5 |
| 2014 | 8 |
| 2015 | 5 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 5 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2026 | 1 |
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 |
|---|---|---|---|---|
| May 6, 2020 | Class I | Z-2263-2020 | Process control | A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer… |
| Sep 20, 2014 | Class I | Z-0125-2015 | Under Investigation by firm | TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step… |
| Oct 19, 2012 | Class II | Z-0288-2013 | Nonconforming Material/Component | Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. TriVascular indicated that these… |
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. 2012, 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/P120006 · printed Nov 6, 2026
Cite this page
510(k) Report. “P120006: Ovation Abdominal Stent Graft System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P120006
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026