SJM™ Masters Series 25MJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734006354), received between Jul 4, 2019 and Jan 10, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2009, A 19MM MASTER'S STANDARD A ORTIC AND 25MM MITRAL MIT WAS REPORTED THAT ON (B)(6) 2009, A 19MM MASTER'S AORTIC MECHANICAL HEART VALVE AND A 25MM MASTERS MITRAL MECHANICAL HEART VALVE WERE SUCCESSFULLY IMPLANTED. IN (B)(6) 2022, THE PATIENT PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH ON EXERTION AND FATIGUE. SINCE SIGNS OF HEART FAILURE WERE OBSERVED, THE PATIENT WAS MANAGED WITH DIURETICS. IN (B)(6) 2022 THE PATIENT VISITED THE HOSPITAL AGAIN WITH ELEVATED LACTATE DEHYDROGENASE (LDH) OF 1968 AND HEMOLYSIS WERE CONFIRMED. IT WAS ACCOMPANIED BY ANEMIA, AND IT WAS DECIDED TO PERFORM A REOPERATION. ULTRASOUND SHOWED PARAVALVULAR LEAK (PVL) IN THE MITRAL VALVE AND 3.95 M/S IN THE AORTIC VALVE, INDICATING SIGNS OF AORTIC STENOSIS (AS). ON (B)(6) 2022, REOPERATION WAS PERFORMED AND BOTH THE 19MM MASTERS AORTIC VALVE AND THE 25MM MASTERS MITRAL VALVE WERE EXPLANTED. NO ABNORMALITIES WERE FOUND IN EITHER VALVES. A NEW 19MM MASTER'S AORTIC MECHANICAL HEART VALVE AND NEW 25MM MASTERS MITRAL MECHANICAL HEART VALVE WERE IMPLANTED AS REPLACEMENTS. PER THE PHYSICIAN, THE MITRAL VALVE HAD PVL AND THE AORTIC VALVE HAD AS DUE TO PANNUS; THERE WAS NO PROBLEM

  Patient problems: Anemia; Dyspnea; Fatigue

  MAUDE report 16131208 ↗
• MalfunctionApr 14, 2021Material Separation; Material Separation

  ON (B)(6) 2021, A 25 MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, WHILE THE DEVICE WAS BEING ROTATED, THE LEAFLET DISLODGED FROM THE VALVE. RESISTANCE WAS NOTED DURING THE ROTATION. THE PHYSICIAN ATTEMPTED TO REINSERT THE LEAFLET, BUT WAS UNSUCCESSFUL. THE DEVICE AND THE DISLODGED INTACT LEAFLET WAS REMOVED AND REPLACED WITH A 25 MM ON-X VALVE TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, BUT THE PROCEDURE WAS EXTENDED LONGER THAN CLINICALLY SIGNIFICANT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11666176 ↗
• InjuryJan 29, 2020Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2018, A 25MM MASTERS SERIES VALVE WAS IMPLANTED. ON AN UNKNOWN DATE PATIENT PRESENT TO THE HOSPITAL AND A THROMBUS ON ONE OF THE LEAFLETS WAS REPORTED. A THROMBOLYTIC THERAPY WAS PERFORMED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS DISCHARGED.

  Patient problems: Thrombus

  MAUDE report 9642477 ↗
• InjuryJan 29, 2020Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2018, A 25MM MASTERS SERIES VALVE WAS IMPLANTED. ON AN UNKNOWN DATE PATIENT PRESENT TO THE HOSPITAL AND A THROMBUS ON ONE OF THE LEAFLETS WAS REPORTED. A THROMBOLYTIC THERAPY WAS PERFORMED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS DISCHARGED.

  Patient problems: Thrombus

  MAUDE report 9642476 ↗
• InjuryJan 29, 2020Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2017, A 25MM MASTERS SERIES VALVE WAS IMPLANTED. ON AN UNKNOWN DATE PATIENT PRESENT TO THE HOSPITAL AND A THROMBUS ON ONE OF THE LEAFLETS WAS REPORTED. A THROMBOLYTIC THERAPY WAS PERFORMED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS DISCHARGED.

  Patient problems: Thrombus

  MAUDE report 9642401 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A 25MM MASTERS VALVE WAS IMPLANTED DUE TO REGURGITATION AND CORONARY HEART DISEASE. DURING A FOLLOW-UP VISIT ON (B)(6) 2018, THE PATIENT WAS NOTED TO HAVE PRE-OPERATIVE VENTRICULAR FIBRILLATION AND POST-OPERATIVE CARDIOGENIC SHOCK. THE PATIENT WAS REPORTED TO HAVE EXPIRED THE SAME DAY DUE TO POST-OPERATIVE COMPLICATIONS. PER THE SITE, THE DEATH IS UNRELATED TO THE DEVICE PERFORMANCE.

  Patient problems: Death; Ventricular Fibrillation

  MAUDE report 9329484 ↗
• InjurySep 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED ON 12 SEPTEMBER 2019 INDICATED THAT THE PATIENT UNDERWENT MITRAL PERIVALVULAR LEAK REPAIR. IT WAS ALSO REPORTED THAT "IT'S NOT THE PERIVALVULAR LEAKAGE THAT'S CAUSED BY THE DAMAGE TO OUR VALVE, IT'S THE WAY THE DOCTOR STITCHED IT UP." ON (B)(6) 2015, A 25MM MASTER MITRAL VALVE AND 19MM REGENT VALVE WERE IMPLANTED AS PART OF A MITRAL VALVE REPLACEMENT AND AORTIC VALVE REPLACEMENT. ON (B)(6) 2016, PERIVALVULAR LEAKAGE WAS OBSERVED AND THE PATIENT WAS TREATED FOR BICUSPID VALVE PERIVALVULAR LEAKAGE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9099284 ↗
• InjuryJul 4, 2019Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2016, A 25MM MASTERS VALVE WAS IMPLANTED. THE PATIENT WAS DIAGNOSED WITH BREAST CANCER AND REQUIRED RADIATION AND SURGERY. DUE TO SURGICAL OPERATIONS, THE PATIENTS ANTICOAGULATION THERAPY WAS STOPPED AND STARTED SEVERAL TIMES RESULTING IN THROMBUS FORMATION. THE PATIENT REPORTED ISSUES OF DYSPNEA. ON (B)(6) 2019, THE DEVICE WAS EXPLANTED DUE TO LEAKAGE. DURING EXPLANT, THROMBUS WAS OBSERVED ON THE PIVOT GUARD. THE PHYSICIAN ATTEMPTED TO CLEAN THE VALVE, BUT THE LEAFLETS DIDN'T FUNCTION CORRECTLY SO THE PHYSICIAN DECIDED TO REPLACE THE VALVE WITH AN EDWARDS TISSUE VALVE. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Regurgitation; Thrombus

  MAUDE report 8761703 ↗