NPWClass 3
Percutaneously Delivered Prostheses And Tricuspid Valves
FDA adverse event reports and recall history for percutaneously delivered prostheses and tricuspid valves (product code NPW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 899
- Deaths
- 79
- Injuries
- 799
- Malfunctions
- 21
Reports per year
13324
33325
43326
Source: FDA adverse event reports by year received, 2024–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-13Open, ClassifiedLabeling design
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Monitor percutaneously delivered prostheses and tricuspid valves automatically
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