PMA · Approved
Recalled · Class I · 2020LOTUS Edge Valve System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Approved on Apr 23, 2019 through premarket approval, which rests on the device’s own clinical evidence after a 252-day review. It has a Class I recall. It has been recalled 6 times, including 6 Class I recalls.
- Decided
- Apr 23, 2019
- Review
- 252 days
- Class
- Class III
- Product code
- NPT
- Recalls
- 6 (6 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P180029 has 28 supplements since 2019: 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 |
|---|---|
| 2019 | 18 |
| 2020 | 9 |
| 2021 | 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 |
|---|---|---|---|---|
| Nov 17, 2020 | Class I | Z-0728-2021 | Device Design | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. |
| Nov 17, 2020 | Class I | Z-0729-2021 | Device Design | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. |
| Nov 17, 2020 | Class I | Z-0734-2021 | Device Design | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. |
| Nov 17, 2020 | Class I | Z-0730-2021 | Device Design | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. |
| Nov 17, 2020 | Class I | Z-0736-2021 | Device Design | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. |
| Nov 17, 2020 | Class I | Z-0735-2021 | Device Design | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NPT devicesNPT Aortic Valve, Prosthesis, Percutaneously Delivered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NPT
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPT
Too few NPT 510(k)s in any year since 2007 to give a median.
Recalls per year · NPT
5in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · NPT
12,906in 2025
MAUDE reports naming product code NPT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 20 | — | 0 | 98 |
| 2013 | 48 | — | 0 | 1,096 |
| 2014 | 56 | — | 4 (3) | 2,161 |
| 2015 | 43 | — | 0 | 2,862 |
| 2016 | 61 | — | 0 | 2,996 |
| 2017 | 65 | — | 1 (1) | 3,115 |
| 2018 | 43 | — | 0 | 3,916 |
| 2019 | 59 | — | 1 | 4,361 |
| 2020 | 48 | — | 9 (6) | 5,806 |
| 2021 | 42 | — | 0 | 5,604 |
| 2022 | 41 | — | 0 | 5,994 |
| 2023 | 49 | — | 0 | 8,319 |
| 2024 | 33 | — | 5 | 11,043 |
| 2025 | 29 | — | 0 | 12,906 |
| 2026 | 34 | — | 3 | — |
https://510kreport.com/device/P180029 · printed Nov 5, 2026
Cite this page
510(k) Report. “P180029: LOTUS Edge Valve System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P180029
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026