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 corpus and the live FDA recall database.
- Total reports
- 965
- Deaths
- 80
- Injuries
- 862
- Malfunctions
- 23
Reports per year
13324
33325
49926
Source: FDA adverse event reports by year received, 2024–2026. Reporting paused twice in 2026 during FDA reporting-system changes 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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