SJM™ Masters Series 25MECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734006347), received between Apr 8, 2019 and Jan 10, 2023 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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.

• DeathJan 10, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2022, A 25MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS SUCCESSFULLY IMPLANTED. PRIOR TO THE IMPLANT PROCEDURE, IT WAS REPORTED THAT THE PATIENT WAS IN MILD-MODERATE HEART FAILURE CONDITION ACCORDING TO THE NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASSIFICATION. ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SYMPTOMS OF SUDDEN ONSET BREATHLESSNESS, WHICH WAS PROGRESSIVE IN NATURE, VOMITING, HYPOTENSION, MULTIPLE ORGAN DYSFUNCTION SYNDROME (MODS), AND CARDIAC ARREST. IT WAS DETERMINED THAT THE MASTERS VALVE WAS STUCK IN THE OPEN POSITION DUE TO A SIGNIFICANT INCREASE IN THE TRANSVALVULAR GRADIENTS ACROSS THE PROSTHETIC MITRAL VALVE. THE PATIENT WAS PLACED ON HIGH INOTROPIC SUPPORTS AND MECHANICAL VENTILATORY SUPPORT. WHILE THROMBOTIC TREATMENT WAS BEING ATTEMPTED BY ADMINISTRATION OF STREPTOKINASE, THE PATIENT EXPIRED. THE PATIENT'S CAUSE OF DEATH WAS MULTIPLE ORGAN DYSFUNCTION SYNDROME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 16130825 ↗
• InjurySep 7, 2022Incomplete Coaptation; Patient-Device Incompatibility; Incomplete Coaptation; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, A SJM MASTERS SERIES VALVE WITH EXPANDED CUFF WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2022, THE PATIENT RETURNED FOR A ROUTINE FOLLOW UP AND WAS DISCOVERED TO HAVE MITRAL VALVE STENOSIS. THE DECISION WAS MADE TO EXPLANT THE SJM MASTERS SERIES VALVE AND REPLACE IT WITH A NON-ABBOTT DEVICE. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 15374490 ↗
• InjuryDec 9, 2021Biocompatibility; Biocompatibility

  T WAS REPORTED ON (B)(6) 2021, A 25MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED. ON AN UNKNOWN DATE THE PATIENT PRESENTED TO A FOLLOW-UP APPOINTMENT IN CLINIC AND A VALVE THROMBOSIS WAS NOTED. A THROMBOLYTIC THERAPY WAS PERFORMED. THE VALVE REMAINS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND SINCE HAS BEEN DISCHARGED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12968938 ↗
• MalfunctionApr 20, 2020Human-Device Interface Problem; Human-Device Interface Problem

  ON (B)(6) 2020, A 25MM MASTERS SERIES VALVE WAS SELECTED FOR IMPLANT. AFTER PLACING THE VALVE THE POSTERIOR LEAFLET WAS INTERFERING WITH THE LEAFLET OPENING AND CLOSING AND THE VALVE WAS REMOVED. A 29MM MASTER SERIES VALVE WAS SELECTED FOR IMPLANTED AND WHILE ROTATING THE VALVE THE LEAFLET CRACKED AND THE VALVE WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER 29MM MASTERS SERIES VALVE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE DUE TO THE REMOVAL OF THE FIRST 2 VALVES. THE PATIENT WAS REPORTED TO BE STABLE CONDITION. MANUFACTURER REPORT NUMBER: 2648612-2020-00038.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9977148 ↗
• InjuryNov 11, 2019Biocompatibility; Biocompatibility

  ON (B)(6) 2010, A 25MM CARPENTIER-EDWARDS PERIMOUNT VALVE WAS IMPLANTED IN THE MITRAL POSITION. ON (B)(6) 2019, THE NON-ABBOTT VALVE WAS EXPLANTED DUE TO CALCIFICATION AND A 25MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED. TWO MONTHS LATER, ON (B)(6) 2019, A RE-DO MVR WAS PERFORMED DUE TO THROMBOSIS ON THE VALVE. IT WAS REPLACED WITH A 23MM MAGNA MITRAL EASE (BY EDWARDS LIFESCIENCES, SERIAL: UNKNOWN). THE PATIENT WAS PRESCRIBED WARFARIN AND WILL FOLLOW UP WITH REGULAR CHECK-INS. DETAILS REGARDING THE PATIENT'S ANTICOAGULATION THERAPY WAS UNKNOWN.

  Patient problems: Thrombosis

  MAUDE report 9307077 ↗
• InjuryApr 8, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2016, A 25MM MASTERS VALVE WAS IMPLANTED IN THE MITRAL POSITION. ON (B)(6) 2019, THE DEVICE WAS EXPLANTED. UPON EXPLANT IT WAS OBSERVED ONE LEAFLET WAS OBSTRUCTED AND NOT FUNCTIONING AS EXPECTED AND THROMBUS WAS OBSERVED. THE PATIENT WAS REPORTED TO HAVE BEEN COMPLIANT WITH THEIR ANTICOAGULATION MEDICATION. SUBSEQUENTLY ANOTHER 25MM VALVE WAS IMPLANTED. THE PATIENT IS REPORTED TO BE STABLE POSTOPERATIVELY.

  Patient problems: Thrombus

  MAUDE report 8492856 ↗