Home › Device types › NPT
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA product code NPT · Class 3 · Unknown
177
Registered devices
78,142
Adverse events
33
Recalls
0
510(k) clearances
Devices with this code
EnVeo™ R — MEDTRONIC COREVALVE LLCEvolut™ FX — MEDTRONIC COREVALVE LLCFlexNav™ — ST. JUDE MEDICAL, INC.CoreValve™ Evolut™ — MEDTRONIC COREVALVE LLCEnVeo™ R — MEDTRONIC COREVALVE LLCCoreValve™ Evolut™ — MEDTRONIC COREVALVE LLCNavitor Titan™ — ST. JUDE MEDICAL, INC.Evolut™ PRO+ — MEDTRONIC COREVALVE LLCCoreValve™ Evolut™ — MEDTRONIC COREVALVE LLCEDWARDS CRIMPER — Edwards Lifesciences LLCCoreValve™ Evolut™ — MEDTRONIC COREVALVE LLCCoreValve™ Evolut™ — MEDTRONIC COREVALVE LLCCRIMPER — Edwards Lifesciences LLCSAPIEN 3 Ultra RESILIA — Edwards Lifesciences LLCEvolut™ FX+ — MEDTRONIC COREVALVE LLC26MM X 3CM X 105CM NOVAFLEX+ DELIVERY SYSTEM — Edwards Lifesciences LLCEDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLCFlexNav™ — ST. JUDE MEDICAL, INC.EnVeo™ PRO — MEDTRONIC, INC.Navitor™ — ST. JUDE MEDICAL, INC.Evolut™ FX — MEDTRONIC COREVALVE LLCEnVeo™ PRO — MEDTRONIC, INC.SAPIEN 3 Ultra System — Edwards Lifesciences LLCSAPIEN 3 Ultra System — Edwards Lifesciences LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-17 | Abbott Medical | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially a |
| 2024-10-17 | Abbott Medical | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially a |
| 2024-10-17 | Abbott Medical | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially a |
| 2024-10-17 | Abbott Medical | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially a |
| 2024-10-17 | Abbott Medical | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially a |
| 2021-06-11 | Medtronic Heart Valves Division | Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. |
| 2021-06-11 | Medtronic Heart Valves Division | Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. |
| 2021-06-11 | Medtronic Heart Valves Division | Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. |
| 2020-11-17 | Boston Scientific Corporation | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery sy |
| 2020-11-17 | Boston Scientific Corporation | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery sy |
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