SJM™ Masters Series 23MJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734006187), received between Sep 24, 2018 and Feb 10, 2021 — classified as 2 injuries.

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

• InjuryFeb 10, 2021Biocompatibility; Biocompatibility

  ON (B)(6) 2020, A 23MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED. THE PATIENT PRESENTED WITH BREATHING DIFFICULTIES AND A VALVE THROMBOSIS WAS NOTED. THE VALVE WAS EXPLANTED ON (B)(6) 2021, UPON EXPLANT A THROMBUS WAS NOTED IN THE HINGE AREA. A 25MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Dyspnea; Thrombosis/Thrombus

  MAUDE report 11306964 ↗
• InjurySep 24, 2018Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2017, A 23 MM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED. POST-IMPLANT, THE PATIENT WAS REPORTED TO HAVE BEEN COMPLIANT WITH THEIR ANTICOAGULATION THERAPY. ON (B)(6) 2018, THE PATIENT PRESENTED WITH COMPLAINTS OF SHORTNESS OF BREATH WITH NO HISTORY OF SYNCOPE. AN ECHO PERFORMED UPON ADMISSION NOTED MITRAL VALVE THROMBUS WITH PEAK GRADIENT/MEAN GRADIENT = 46/38 MMHG. THE PATIENT WAS TRANSFERRED TO THE CCU FROM THE EMERGENCY DEPARTMENT FOR CLOSE OBSERVATION AND MONITORING. SHE WAS STARTED ON MANAGEMENT OF HEART FAILURE. FLUOROSCOPY AND 2D ECHO WAS DONE WHICH SHOWED THE VALVE TO BE STUCK. THE PATIENT WAS TREATED WITH STREPTOKINASE (STK) AND AFTER 24 HOURS OF THROMBOLYSIS, ONE LEAFLET REGAINED MOBILITY BUT ANOTHER WAS STUCK WITH PG/MG = 20/13 MMHG. STK WAS CONTINUED FOR ANOTHER 24 HOURS. FLUOROSCOPY AFTER 40 HOURS REVEALED NORMAL MOBILITY OF THE LEAFLET AND PG/MG ACROSS MITRAL VALVE PROSTHESIS DECREASED TO 6/3 ON 2D ECHO. THE PATIENT RESPONDED WELL TO THE TREATMENT AND RECOVERED SYMPTOMATICALLY. THE HOSPITAL STAY WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7904474 ↗