Masters Series™ 29MECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067045256), received between Apr 1, 2024 and Apr 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Perivalvular Leak” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2024Perivalvular Leak; Perivalvular Leak

  IT WAS NOTED THAT ON (B)(6) 2024, A 29MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS CHOSEN FOR A PROCEDURE. THE VALVE WAS IMPLANTED. ONE MINUTE AFTER THE IMPLANTATION, A MODERATE VALVULAR LEAK WAS NOTED. THE VALVE WAS EXPLANTED AND MITRAL VALVE REPLACEMENT (MVR) WAS DONE WITH A NEW 29MM SJM MASTERS SERIES VALVE EXPANDED CUFF INTRA-PROCEDURALLY, WHILE THE PATIENT WAS STILL ON BYPASS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19015678 ↗