Home › Device types › NPT
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA product code NPT · Class 3 · Unknown
177
Registered devices
79,967
Adverse events
36
Recalls
0
510(k) clearances
Devices with this code
LOTUS Edge™ Valve System — BOSTON SCIENTIFIC CORPORATIONTrilogy Loading Tools — Jenavalve Technology, Inc.CoreValve™ Evolut™ PRO — MEDTRONIC COREVALVE LLCEdwards SAPIEN 3 Ultra Transcatheter Heart Valve — Edwards Lifesciences LLCEnVeo™ R — MEDTRONIC COREVALVE LLCCoreValve™ Evolut™ — MEDTRONIC COREVALVE LLCSAPIEN 3 Ultra RESILIA — Edwards Lifesciences LLCCoreValve™ — MEDTRONIC COREVALVE LLCEnVeo™ R — MEDTRONIC COREVALVE LLCTrilogy Transcatheter Heart Valve — Jenavalve Technology, Inc.Evolut™ FX+ — MEDTRONIC COREVALVE LLCEdwards Certitude Delivery System — Edwards Lifesciences LLCLOTUS Edge™ Valve System — BOSTON SCIENTIFIC CORPORATIONCoreValve™ Evolut™ PRO — MEDTRONIC COREVALVE LLC18F X 36CM EDWARDS EXPANDABLE INTRODUCER SHEATH SET — Edwards Lifesciences LLCASCENDRA 3 INTRODUCER SHEATH SET — Edwards Lifesciences LLCSAPIEN 3 Ultra System — Edwards Lifesciences LLCSAPIEN 3 Ultra delivery system — Edwards Lifesciences LLCEDWARDS DILATOR KIT — Edwards Lifesciences LLCPortico™ — ST. JUDE MEDICAL, INC.Evolut™ FX — MEDTRONIC COREVALVE LLCNavitor Titan™ — ST. JUDE MEDICAL, INC.24F (7.9MM) X 25CM ASCENDRA+ INTRODUCER SHEATH SET — Edwards Lifesciences LLCNavitor™ — ST. JUDE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-31 | Jenavalve Technology Inc. | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. |
| 2026-07-31 | Jenavalve Technology Inc. | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. |
| 2026-07-31 | Jenavalve Technology Inc. | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. |
| 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. |
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