PMA · Approved
Recalled · Class II · 2020Excluder Bifurcated Endoprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Approved on Nov 6, 2002 through premarket approval, which rests on the device’s own clinical evidence after a 287-day review. It has been recalled 2 times.
- Decided
- Nov 6, 2002
- Review
- 287 days
- Class
- Class III
- Product code
- MIH
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P020004 has 199 supplements since 2003: 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 |
|---|---|
| 2003 | 4 |
| 2004 | 4 |
| 2005 | 5 |
| 2006 | 2 |
| 2007 | 14 |
| 2008 | 7 |
| 2009 | 9 |
| 2010 | 10 |
| 2011 | 10 |
| 2012 | 12 |
| 2013 | 8 |
| 2014 | 19 |
| 2015 | 14 |
| 2016 | 17 |
| 2017 | 8 |
| 2018 | 11 |
| 2019 | 9 |
| 2020 | 5 |
| 2021 | 8 |
| 2022 | 8 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 8 |
| 2026 | 4 |
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.
Planning a device in MIH? 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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2020 | Class II | Z-0996-2020 | Employee error | Firm has received reports of leading end catheter component separations. |
| Jan 6, 2020 | Class II | Z-0995-2020 | Employee error | Firm has received reports of leading end catheter component separations. |
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.
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/P020004 · printed Nov 6, 2026
Cite this page
510(k) Report. “P020004: Excluder Bifurcated Endoprosthesis.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P020004
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026