PMA · Approved
Recalled · Class II · 2016Perceval Sutureless Heart Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corcym S.r.l. · LWR Heart-Valve, Non-Allograft Tissue
Approved on Jan 8, 2016 through premarket approval, which rests on the device’s own clinical evidence after a 312-day review. It has been recalled once.
- Decided
- Jan 8, 2016
- Review
- 312 days
- Class
- Class III
- Product code
- LWR
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P150011 has 34 supplements since 2016: 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 |
|---|---|
| 2016 | 5 |
| 2017 | 5 |
| 2018 | 2 |
| 2019 | 4 |
| 2020 | 4 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 7 |
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 LWR? 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 |
|---|---|---|---|---|
| Oct 31, 2016 | Class II | Z-0716-2017 | Use error | Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LWR devicesLWR Heart-Valve, Non-Allograft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LWR
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWR
Too few LWR 510(k)s in any year since 2007 to give a median.
Recalls per year · LWR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWR
1,866in 2025
MAUDE reports naming product code LWR, 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 | 8 | — | 0 | 703 |
| 2008 | 7 | — | 0 | 1,552 |
| 2009 | 15 | — | 0 | 376 |
| 2010 | 17 | — | 0 | 279 |
| 2011 | 25 | — | 0 | 258 |
| 2012 | 18 | — | 0 | 718 |
| 2013 | 31 | — | 0 | 326 |
| 2014 | 27 | — | 1 | 365 |
| 2015 | 14 | — | 0 | 525 |
| 2016 | 27 | — | 1 | 736 |
| 2017 | 54 | — | 0 | 1,367 |
| 2018 | 64 | — | 0 | 1,593 |
| 2019 | 50 | — | 0 | 1,855 |
| 2020 | 32 | — | 0 | 1,437 |
| 2021 | 18 | — | 0 | 1,550 |
| 2022 | 37 | — | 0 | 1,084 |
| 2023 | 26 | — | 0 | 1,592 |
| 2024 | 27 | — | 0 | 1,829 |
| 2025 | 27 | — | 0 | 1,866 |
| 2026 | 19 | — | 0 | — |
https://510kreport.com/device/P150011 · printed Nov 6, 2026
Cite this page
510(k) Report. “P150011: Perceval Sutureless Heart Valve.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P150011
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026