PMA · Approved
Recalled · Class II · 2014Edwards Sapien 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 Nov 2, 2011 through premarket approval, which rests on the device’s own clinical evidence after a 366-day review. It has been recalled 3 times.
- Decided
- Nov 2, 2011
- Review
- 366 days
- Class
- Class III
- Product code
- NPT
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P100041 has 64 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 | 17 |
| 2013 | 23 |
| 2014 | 16 |
| 2015 | 6 |
| 2016 | 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 NPT? 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 20, 2014 | Class II | Z-0918-2014 | Nonconforming Material/Component | Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a… |
| Mar 26, 2013 | Class II | Z-1134-2013 | Package design/selection | Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers. |
| Mar 26, 2013 | Class II | Z-1135-2013 | Package design/selection | Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers. |
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. 2011, 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/P100041 · printed Nov 6, 2026
Cite this page
510(k) Report. “P100041: Edwards Sapien Transcatheter Heart Valve and Accessories.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P100041
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026