Aortic Valve, Prosthesis, Percutaneously Delivered
FDA adverse event reports and recall history for aortic valve, prosthesis, percutaneously delivered (product code NPT), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 79,969
- Deaths
- 8,069
- Injuries
- 59,644
- Malfunctions
- 12,240
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-10-09Open, ClassifiedNonconforming Material/Component
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- 2026-10-09Open, ClassifiedNonconforming Material/Component
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- 2026-10-09Open, ClassifiedNonconforming Material/Component
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- 2024-11-20Open, ClassifiedUnder Investigation by firm
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- 2024-11-20Open, ClassifiedUnder Investigation by firm
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- 2024-11-20Open, ClassifiedUnder Investigation by firm
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- 2024-11-20Open, ClassifiedUnder Investigation by firm
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- 2024-11-20Open, ClassifiedUnder Investigation by firm
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- 2021-01-09TerminatedDevice Design
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
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 system.
- 2021-01-09TerminatedDevice Design
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
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 system.
Monitor aortic valve, prosthesis, percutaneously delivered automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.