PMA · Approved
Recalled · Class I · 2019Sapien 3 Transcatheter Heart Valve and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Approved on Jun 17, 2015 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 a Class I recall.
- Decided
- Jun 17, 2015
- Review
- 177 days
- Class
- Class III
- Product code
- NPT
- Recalls
- 3 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P140031 has 202 supplements since 2015: 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 |
|---|---|
| 2015 | 1 |
| 2016 | 24 |
| 2017 | 31 |
| 2018 | 21 |
| 2019 | 19 |
| 2020 | 21 |
| 2021 | 14 |
| 2022 | 10 |
| 2023 | 20 |
| 2024 | 13 |
| 2025 | 14 |
| 2026 | 14 |
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 |
|---|---|---|---|---|
| Jan 22, 2019 | Class II | Z-0835-2019 | Labeling design | This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures. |
| Jun 11, 2018 | Class II | Z-2435-2018 | Labeling False and Misleading | SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. |
| Jul 21, 2017 | Class I | Z-0293-2018 | Employee error | A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient. |
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. 2015, 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/P140031 · printed Nov 4, 2026
Cite this page
510(k) Report. “P140031: Sapien 3 Transcatheter Heart Valve and Accessories.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P140031
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026