Pulmonic Valved Conduit
FDA adverse event reports and recall history for pulmonic valved conduit (product code MWH), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 1,133
- Deaths
- 50
- Injuries
- 1,055
- Malfunctions
- 27
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
- 2006-03-25TerminatedOther
Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc., 650 Liberty Ave., Union, NJ 07083 USA'** **'Shelhigh Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React' treatment*, INSTRUCTIONS FOR USE'**.
Unapproved Device-Distribution of an unapproved device into interstate commerce.
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