Medtronic Heart Valves Division
1851 EAST DEERE AVE., Santa Ana, CA, US
Registered product codes
12 product codes
Recent MDR events
43,484 on file
- Mosaic Aortic Bioprosthetic Heart ValveJul 31, 2026Injury2025587-2026-00814
- MOSAICJul 30, 2026Malfunction2025587-2026-00841
- Mosaic Aortic Bioprosthetic Heart ValveJul 30, 2026Injury2025587-2026-00842
- Freestyle Aortic Root BioprosthesisJul 30, 2026Injury2025587-2026-00843
- Medtronic Surgical Tissue ValveJul 30, 2026Injury2025587-2026-00844
- Mosaic Aortic Bioprosthetic Heart ValveJul 30, 2026Injury2025587-2026-00822
- Hancock II Aortic Bioprosthetic Heart ValveJul 30, 2026Injury2025587-2026-00823
- Mosaic Mitral Bioprosthetic Heart ValveJul 29, 2026Injury2025587-2026-00827
- Freestyle Aortic Root BioprosthesisJul 29, 2026Injury2025587-2026-00828
- Hancock II Aortic Bioprosthetic Heart ValveJul 29, 2026Injury2025587-2026-00821
Recalls
7 on file
- Open, ClassifiedJul 2, 2026
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
View FDA record ↗ - TerminatedUnknown
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
View FDA record ↗ - TerminatedUnknown
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
View FDA record ↗ - TerminatedUnknown
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
View FDA record ↗ - Open, ClassifiedUnknown
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
View FDA record ↗ - Open, ClassifiedUnknown
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
View FDA record ↗ - Open, ClassifiedUnknown
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
View FDA record ↗
Compliance history
Matched by FEI 2025587.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.