LWQFDA Class 3 · implantable
Heart-Valve, Mechanical
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
383
Manufacturers
9
Flagged signals
15
Adverse-event reports
4,262
Code matrix
| FDA product code | LWQ |
| Device class | Class 3 |
| Regulation | — |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | Yes |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 4 | 532.0 | 1,625 |
| Other | 2011 | 3 | 332.5 | 689 |
| Death | 2010 | 6 | 42.6 | 206 |
| Death | 2013 | 4 | 34.9 | 101 |
| Death | 2020 | 3 | 28.4 | 55 |
| Death | 2020 | 6 | 15.8 | 70 |
| Death | 2011 | 3 | 15.5 | 28 |
| Death | 2020 | 3 | 11.7 | 20 |
| Death | 2021 | 8 | 8.3 | 44 |
| Death | 2019 | 3 | 7.9 | 12 |
| Death | 2018 | 28 | 4.1 | 63 |
| Death | 2022 | 12 | 3.2 | 16 |
| Death | 2023 | 11 | 2.9 | 12 |
| Death | 2017 | 18 | 2.6 | 17 |
| Death | 2024 | 15 | 2.2 | 9 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 4,262 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Abbott Medical | 121 | 2025 | — |
| ON-X LIFE TECHNOLOGIES, INC. | 64 | 2026 | — |
| Corcym S.r.l. | 63 | 2025 | — |
| Medtronic Ats Medical, Inc. | 60 | 2023 | — |
| Medtronic Cardiac Surgery | 50 | 2009 | — |
| Edwards Lifesciences, LLC | 9 | 2007 | — |
| Medical Cv, Inc. | 8 | 2002 | — |
| Shiley, Inc. | 6 | 1986 | — |
| Alliance Medical Technologies, Inc. | 2 | 1998 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
On-X Prosthetic Heart Valves and Ascending Aortic Prothesis · On-X Life Technologies, Inc.PMA · 2026-01-05
On-X Ascending Aortic Prosthesis · On-X Life Technologies, Inc.PMA · 2025-12-17
Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros · Corcym S.r.l.PMA · 2025-12-17
On-X Prosthetic Heart Valves; On-X Ascending Aortic Prothesis · On-X Life Technologies, Inc.PMA · 2025-10-22
On-X Heart Valve; On-X Ascending Aortic Prosthesis · On-X Life Technologies, Inc.PMA · 2025-10-22
On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (AAP) · On-X Life Technologies, Inc.PMA · 2025-10-22
On-X Prosthetic Heart Valves and Ascending Aortic Prothesis · On-X Life Technologies, Inc.PMA · 2025-10-22
Masters Series Mechanical Heart Valve · ABBOTT MEDICALPMA · 2025-10-15
CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V · Corcym S.r.l.PMA · 2025-05-15
Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Series Aortic Valved Graft with Hemashield · ABBOTT MEDICALPMA · 2025-02-20
Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) · ABBOTT MEDICALPMA · 2024-08-15
Carbomedics Prosthetic Heart Valve, Carbomedics Supra-Annular Prosthetic Heart Valve (Top Hat), Carbo-Seal Ascending Aor · Corcym S.r.l.PMA · 2024-07-09
Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ) · ABBOTT MEDICALPMA · 2024-07-02
Carbomedics Prosthetic Heart Valve · Corcym S.r.l.PMA · 2024-04-09
Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology · ABBOTT MEDICALPMA · 2024-04-03
On-X Prosthetic Heart Valve · On-X Life Technologies, Inc.PMA · 2024-03-05
SJM Masters Series Mechanical Heart Valve, 15mm HP · ABBOTT MEDICALPMA · 2023-12-04
On-X Prosthetic Heart Valve and Ascending Aortic Prothesis · On-X Life Technologies, Inc.PMA · 2023-11-08
Open Pivot heart valve · Medtronic Ats Medical, Inc.PMA · 2023-11-07
SJM Masters Series Mechanical Heart Valve, SJM Regent Mechanical Heart Valve, SJM Masters Series Aortic Valved Graft · ABBOTT MEDICALPMA · 2023-10-18
Medtronic Open Pivot Aortic Valved Graft (AVG) · Medtronic Ats Medical, Inc.PMA · 2023-07-19
Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) · ABBOTT MEDICALPMA · 2023-03-31
BILEAFLET-CENTER OPENING CARDIAC VALVE · ABBOTT MEDICALPMA · 2023-03-28
Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valved Graft with Hemashield graft technology (C · ABBOTT MEDICALPMA · 2023-01-27
CARBOMEDICS Prosthetic Heart Valve (CPHV) · Corcym S.r.l.PMA · 2023-01-13
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.