Masters Series™ 25AJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067043054), received between Aug 9, 2024 and Apr 10, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT SURGERY. THE LEAFLET FUNCTION WAS TESTED USING A MECHANICAL HEART VALVE LEAFLET TESTER (LT100). DURING THE OPERATION, WHEN THE VALVE WAS SUCCESSFULLY IMPLANTED, THE PHYSICIAN FOUND THAT THE VALVE LEAFLETS WERE NOT OPENING PROPERLY DUE TO THE OBSTRUCTION OF TISSUE STRUCTURE UNDER THE VALVE. SO, THE VALVE WAS REMOVED AND REPLACED BY ANOTHER 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE WHILE PATIENT ON BYPASS. THE OPERATION WAS FINALLY COMPLETED, AND THE PATIENT WAS IN STABLE CONDITION. THERE WAS PROLONGED THE DURATION OF CARDIOPULMONARY BYPASS OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845660 ↗
• MalfunctionOct 15, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE CHOSEN FOR A Y-INCISION AORTIC VALVE REPLACEMENT PROCEDURE. THE LEAFLET FUNCTION WAS TESTED BY USING A PLASTIC TESTER. AFTER IMPLANTATION OF THE VALVE, THE PHYSICIAN FOUND ONE LEAFLET OF THE VALVE COULDN'T MOVE FLEXIBLY. SO, THE PHYSICIAN HAD TO EXPLANT THE VALVE AND IMPLANTED A NEW 23MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE. THE LEAFLET FUNCTION WAS TESTED BY USING A PLASTIC TESTER. BUT THE LEAFLET OF THE 23MM VALVE COULDN'T MOVE FLEXIBLY AGAIN, THE DOCTOR HAD TO EXPLANT THE 23MM VALVE AGAIN AND A NEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED. THE VALVE WAS MOVED NORMALLY. THE PROCEDURE TIME WAS EXTENDED ABOUT 60 MINUTES. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285551 ↗
• InjuryAug 9, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANT. DURING DEVICE PREPARATION, THE LEAFLET MOVEMENT WAS TESTED BY ABBOTT SOFT PEN, AND LEAFLETS WERE MOVING NORMALLY WHEN TESTED. THE VALVE WAS IMPLANTED, AND IT WAS NOTED THAT ONE LEAFLET DID NOT MOVE. THE VALVE WAS EXPLANTED AND REPLACED WITH A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE. AFTER THE EXPLANT, THE LEAFLET WAS MOVING PROPERLY WHEN TESTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT REQUIRED LONGER INTERMEDIATE SURGICAL UNIT (ISU) STAY DUE TO RESPIRATORY FAILURE. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Respiratory Insufficiency

  MAUDE report 19950591 ↗