PMA · Approved
Recalled · Class II · 2020Ats Open Pivot Bileaflet Heart Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Ats Medical, Inc. · LWQ Heart-Valve, Mechanical
Approved on Oct 13, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 442-day review. It has been recalled 2 times.
- Decided
- Oct 13, 2000
- Review
- 442 days
- Class
- Class III
- Product code
- LWQ
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P990046 has 59 supplements since 2001: 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 |
|---|---|
| 2001 | 3 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 4 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 4 |
| 2013 | 7 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 6 |
| 2017 | 4 |
| 2018 | 1 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 5 |
| 2023 | 2 |
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 LWQ? 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 |
|---|---|---|---|---|
| Feb 11, 2020 | Class II | Z-1533-2020 | Labeling mix-ups | Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral. |
| Feb 18, 2004 | Not classified | Z-0634-04 | Other | Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LWQ devicesLWQ Heart-Valve, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWQ
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWQ
Too few LWQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWQ
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWQ
330in 2025
MAUDE reports naming product code LWQ, 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 | 12 | — | 0 | 88 |
| 2008 | 15 | — | 0 | 90 |
| 2009 | 8 | — | 0 | 91 |
| 2010 | 6 | — | 0 | 119 |
| 2011 | 16 | — | 0 | 139 |
| 2012 | 21 | — | 0 | 122 |
| 2013 | 17 | — | 0 | 134 |
| 2014 | 11 | — | 0 | 134 |
| 2015 | 14 | — | 0 | 139 |
| 2016 | 13 | — | 0 | 202 |
| 2017 | 11 | — | 0 | 299 |
| 2018 | 8 | — | 0 | 434 |
| 2019 | 4 | — | 0 | 350 |
| 2020 | 6 | — | 0 | 372 |
| 2021 | 9 | — | 0 | 287 |
| 2022 | 8 | — | 0 | 297 |
| 2023 | 9 | — | 0 | 455 |
| 2024 | 6 | — | 0 | 404 |
| 2025 | 9 | — | 0 | 330 |
| 2026 | 5 | — | 1 | — |
https://510kreport.com/device/P990046 · printed Nov 6, 2026
Cite this page
510(k) Report. “P990046: Ats Open Pivot Bileaflet Heart Valve.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P990046
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026