LWRFDA Class 3 · implantable
Heart-Valve, Non-Allograft Tissue
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
570
Manufacturers
8
Flagged signals
23
Adverse-event reports
17,781
Code matrix
| FDA product code | LWR |
| Device class | Class 3 |
| Regulation | — |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 10 | 604.7 | 5,445 |
| Other | 2013 | 8 | 204.6 | 1,426 |
| Other | 2013 | 11 | 138.1 | 1,364 |
| Other | 2014 | 5 | 127.9 | 510 |
| Other | 2012 | 9 | 112.9 | 891 |
| Other | 2010 | 8 | 100.4 | 692 |
| Death | 2023 | 3 | 85.2 | 174 |
| Other | 2011 | 6 | 75.3 | 369 |
| Other | 2012 | 4 | 50.2 | 147 |
| Other | 2013 | 4 | 50.2 | 147 |
| Death | 2010 | 14 | 7.2 | 69 |
| Death | 2019 | 4 | 5.3 | 10 |
| Death | 2025 | 6 | 5.3 | 17 |
| Death | 2021 | 31 | 4.8 | 91 |
| Death | 2024 | 5 | 4.4 | 10 |
| Death | 2025 | 3 | 4.2 | 5 |
| Death | 2020 | 3 | 4.0 | 4 |
| Death | 2011 | 4 | 3.7 | 5 |
| Death | 2011 | 6 | 3.1 | 6 |
| Injury | 2010 | 4 | 2.6 | 4 |
| Death | 2017 | 8 | 2.5 | 6 |
| Death | 2017 | 26 | 2.3 | 17 |
| Injury | 2011 | 9 | 2.1 | 7 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 17,781 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Edwards Lifesciences, LLC | 171 | 2026 | — |
| Medtronic, Inc. | 150 | 2026 | — |
| Abbott Medical | 102 | 2025 | — |
| Medtronic Heart Valves | 63 | 2025 | — |
| Corcym Canada Corp | 44 | 2022 | — |
| Corcym S.r.l. | 35 | 2025 | — |
| ST. JUDE MEDICAL, INC. | 4 | 2006 | — |
| Medtronic, Inc. Heart Valve Division | 1 | 2017 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Valved Conduit · Edwards Lifesciences, LLCPMA · 2026-04-16
Avalus Bioprosthesis · Medtronic, Inc.PMA · 2026-04-09
Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process; Carpentier-Edwar · Edwards Lifesciences, LLCPMA · 2026-03-11
INSPIRIS RESILIA Aortic Valve; KONECT RESILIA Aortic Valve Conduit (AVC); MITRIS RESILIA Mitral Valve · Edwards Lifesciences, LLCPMA · 2026-03-11
Freestyle Bioprosthesis · Medtronic, Inc.PMA · 2026-02-12
Avalus Bioprostheses · Medtronic, Inc.PMA · 2026-02-12
TRIFORMIS RESILIA Tricuspid Valve, Model 11300T · Edwards Lifesciences, LLCPMA · 2026-02-06
TRIFORMIS RESILIA Tricuspid Valve, Model 11300T · Edwards Lifesciences, LLCPMA · 2026-02-06
Avalus Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus Ultra Bioprosthesis Model 400 (400U1 · Medtronic, Inc.PMA · 2026-02-04
Perceval Sutureless Heart Valve · Corcym S.r.l.PMA · 2025-12-22
Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, Sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm; Edwards KONECT RESILI · Edwards Lifesciences, LLCPMA · 2025-12-17
Freestyle Bioprosthesis · Medtronic, Inc.PMA · 2025-11-10
Avalus Bioprosthesis, Avalus Ultra Bioprosthesis · Medtronic, Inc.PMA · 2025-11-10
Epic, Epic Supra, Epic Plus, Epic Plus Supra and Epic Max Stented Tissue Valve · ABBOTT MEDICALPMA · 2025-10-30
Avalus Bioprosthesis · Medtronic, Inc.PMA · 2025-10-30
PERCEVAL SUTURELESS HEART VALVE · Corcym S.r.l.PMA · 2025-10-28
Perceval Sutureless Heart Valve · Corcym S.r.l.PMA · 2025-10-28
TRIFORMIS RESILIA Tricuspid Valve · Edwards Lifesciences, LLCPMA · 2025-10-27
Freestyle Bioprosthesis, Models 995, 995CS, 995MS · Medtronic, Inc.PMA · 2025-10-23
Avalus Bioprosthesis, Model 400 · Medtronic, Inc.PMA · 2025-10-23
EDWARDS INTUITY Elite Valve · Edwards Lifesciences, LLCPMA · 2025-10-16
INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve · Edwards Lifesciences, LLCPMA · 2025-10-16
Epic Plus Stented Tissue Valve; Epic Max Stented Tissue Valve · ABBOTT MEDICALPMA · 2025-07-29
Avalus Bioprosthesis, Model 400 · Medtronic, Inc.PMA · 2025-06-26
Avalus Bioprosthesis, Model 400 · Medtronic, Inc.PMA · 2025-06-26
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.