Masters Series™ 31MJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05415067045072), received between Oct 29, 2024 and Oct 21, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2025, THE PATIENT ADMITTED TO HOSPITAL AND INTUBATED, WITH PULMONARY EDEMA. THE MECHANICAL VALVE WAS FOUND TO BE MALFUNCTIONING. INTRAOPERATIVELY, ONE VALVE LEAFLET WAS FOUND TO BE MISSING. THE VALVE WAS REPLACED WITH A NEW 31MM SJM MASTERS SERIES MECHANICAL HEART VALVE. THE LEAFLET WAS IDENTIFIED ON COMPUTED TOMOGRAPHY (CT). A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE LEAFLET WITHIN THE ABDOMINAL AORTA AT THE BIFURCATION.

  Patient problems: Pulmonary Edema

  MAUDE report 23352792 ↗
• InjuryAug 18, 2025Fracture; Intravalvular regurgitation; Fracture; Intravalvular regurgitation

  CLINICAL INFORMATION: (B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM MASTERS SERIES MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. A POSTOPERATIVE ECHOCARDIOGRAM IN THE INTENSIVE CARE UNIT (ICU) SHOWED SEVERE GRADE 3-4 MITRAL REGURGITATION, LEADING TO REOPERATION WITHIN 24 HOURS. DURING REOPERATION, AN ATTEMPT TO ROTATE A 31MM NON-ABBOTT REPLACEMENT VALVE, A RUPTURE OCCURRED. THE PATIENT REQUIRED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) IMPLANTATION, FOLLOWED BY ANOTHER OPERATION DUE TO BLEEDING. ULTRASOUND AGAIN SHOWED ABNORMALITIES IN THE 31MM NON-ABBOTT REPLACEMENT VALVE, SPECIFICALLY A FIXED POSTERIOR DISC, LEADING TO ANOTHER REOPERATION AND REPLACEMENT WITH A 29MM EPIC PLUS MITRAL VALVE. ON (B)(6) 2025, IT'S NOTED THAT THE PATIENT BEGAN SUFFERING FROM CARDIAC TAMPONADE. CARDIAC TAMPONADE WAS CONFIRMED BY TRANSESOPHAGEAL ULTRASOUND AFTER THE PATIENT, WHO HAD BEEN PROGRESSING FAVORABLY, EXPERIENCED SUDDEN HEMODYNAMIC DETERIORATION. DAILY ULTRASOUND STUDIES PERFORMED AT THE BEDSIDE IN THE ICU DID NOT REVEAL ANY PERICARDIAL EFFUSION PRIOR TO CONFIRMING CARDIAC TAMPONADE. A SURGICAL REVISION/INTERVENTION WAS PERF

  Patient problems: Angina; Cardiac Tamponade; Mitral Valve Insufficiency/ Regurgitation; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 22829913 ↗
• InjuryFeb 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2006, A 31MM SJM MASTERS SERIES MECHANICAL HEART VALVE AND ON AN UNKNOWN DATE A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, BOTH THE VALVES WERE EXPLANTED AND A NEW 27MM NON-ABBOTT VALVE AND 31MM EPIC MITRAL VALVE WERE IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 21323203 ↗
• MalfunctionDec 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B (6) 2024, A 31MM MASTERS MITRAL MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING IMPLANT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS UTILIZED AND IT WAS OBSERVED THAT ONE LEAFLET "DOESN'T WORK NORMAL" AND WAS NOT IMPLANTED. THE PATIENT STATUS IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924511 ↗
• InjuryNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024, A 31MM MASTERS VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, AFTER IMPLANTING THE VALVE, IT WAS NOTICED THAT THE VALVE FIN CAME OFF IN ONE PIECE. WHILE STILL ON BYPASS, THE VALVE FIN AND DEVICE WERE REMOVED FROM THE PATIENT, AND A NEW VALVE WAS IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791814 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2024, A 31MM SJM MASTERS SERIES VALVE EXPANDED CUFF VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE SURGEON WAS SUTURING THE VALVE IN PLACE AND POSSIBLY ATTEMPTED TO REPOSITION VALVE AND SOMEHOW ONE OF THE PIECES CAME OFF. THE VALVE WAS EXPLANTED AND A NEW 31MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS CHOSEN AND COMPLETED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557251 ↗