Pulmonary Valve Prosthesis Percutaneously Delivered
FDA adverse event reports and recall history for pulmonary valve prosthesis percutaneously delivered (product code NPV), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,238
- Deaths
- 77
- Injuries
- 1,760
- Malfunctions
- 401
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-07-02Open, ClassifiedProcess control
Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
- 2022-04-18Open, ClassifiedUnder Investigation by firm
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
There is potential for the capsule bond to break during the procedure.
Monitor pulmonary valve prosthesis percutaneously delivered automatically
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