Masters Series™ 25MJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067045010), received between Oct 26, 2023 and Oct 29, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024 , A 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THERE WAS POOR OPENING AND CLOSING OF VALVE LEAFLETS. DEVICE WAS REPLACED WITH A NEW 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE THAT SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558761 ↗
• MalfunctionOct 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, AT THE TIME OF INSTALLATION IT DEVELOPED CRUMBLING AND BROKE AND WAS RECOVERED FROM THE PATIENT. DEVICE WAS REPLACED WITH AN UNKNOWN DEVICE THAT COMPLETED THE PROCEDURE. THE PATIENT IS STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014137 ↗