SJM™ Masters Series 31MJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734006620), received between Nov 8, 2018 and Jul 28, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2022Incomplete Coaptation; Patient Device Interaction Problem; Incomplete Coaptation; Patient Device Interaction Problem

  THE ARTICLE, "THROMBOSED STUCK MITRAL VALVE DURING ADVANCED MECHANICAL CIRCULATORY SUPPORT FOR POST-CARDIOTOMY SHOCK", WAS REVIEWED. THIS ARTICLE PRESENTED A CASE STUDY OF A 52 YEAR OLD PATIENT WITH A PREVIOUS DIAGNOSIS OF IDIOPATHIC DILATED CARDIOMYOPATHY AND HISTORY OF HEPATITIS C. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR DECOMPENSATED ACUTE HEART FAILURE WITH SEVERE LEFT VENTRICLE (LV) DYSFUNCTION AND MITRAL REGURGITATION (MR). THE PATIENT WAS NOT A HEART TRANSPLANT CANDIDATE BECAUSE OF THEIR HISTORY OF DRUG ABUSE. THE PATIENT WAS DOBUTAMINE DEPENDENT WITH A INTRA-AORTIC BALLOON PUMP (IABP). URGENT MITRAL VALVE REPLACEMENT (MVR) WAS REQUIRED DUE TO HEART FAILURE THAT WAS DIFFICULT TO CONTROL. A 31 MM SJM MECHANICAL HEART VALVE WAS IMPLANTED AND A 32 MM NON-ABBOTT TRICUSPID ANNULOPLASTY RING WAS IMPLANTED. THE PATIENT WAS UNSUCCESSFULLY WEANED FROM CARDIOPULMONARY BYPASS (CPB) DUE TO SEVERE RIGHT VENTRICLE (RV) AND LV DYSFUNCTIONS. THE IABP WAS REMOVED AND REPLACED WITH ECPELLA, VA-ECMO WITH LEFT FEMORAL CANNULATION FOR RV FAILURE AND SEVERE HYPOXIA. ALSO IMPELLA 2.5 VIA THE RIGHT FEMORAL ARTERY TO UNLOAD THE IMPAIRED LV. AN ACTIVATED CLOTTING TIME OF 160 SECONDS WAS ATTEMPTE

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Hypoxia; Mitral Valve Insufficiency/ Regurgitation; Respiratory Insufficiency; Thrombosis/Thrombus

  MAUDE report 15118739 ↗
• InjuryJan 12, 2021Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2020 A 31MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED IN THE PATIENT'S MITRAL POSITION A SJM SIZER WAS USED IN THE SURGERY. A PVL OCCURRED ON THE PATIENT LEADING TO RE-DO MVR WAS PERFORMED ON (B)(6) 2020, AND THE MASTERS VALVE WAS EXPLANTED, REPLACED WITH A MOSAIC BIOPROSTHESIS(MANUFACTURER: MEDTRONIC). THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE MVR, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE SURGERY. THE PATIENT IS IN STABLE CONDITION POSTOPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11154006 ↗
• InjuryJan 12, 2020Material Integrity Problem; Material Integrity Problem

  ON AN UNKNOWN DATE, A 31MM MASTERS VALVE WAS SELECTED FOR IMPLANT IN THE MITRAL POSITION. WHEN IMPLANTING, THE VALVE BROKE. ANOTHER 31MM MASTERS VALVE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9579539 ↗
• InjuryMay 24, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2019, A 31MM MASTERS VALVE WAS IMPLANTED IN A (B)(6) MALE. FOLLOWING IMPLANT, AN ECHO REVEALED IMPROPER LEAFLET FUNCTION AND THE PATIENT WAS REPORTED TO BE HEMODYNAMICALLY UNSTABLE. THE VALVE WAS EXCHANGED FOR ANOTHER 31MM MASTERS VALVE (SERIAL NUMBER: (B)(4)) AND THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641223 ↗
• InjuryApr 29, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2019, A 31MM MASTERS VALVE WAS IMPLANTED IN THE MITRAL POSITION. POST PROCEDURE AFTER CLOSING THE CHEST, THE PHYSICIAN OBSERVED THAT ONE OF THE LEAFLETS WAS NOT MOVING PROPERLY. THE CHEST WAS REOPENED AND THE PHYSICIAN EXPLANTED THE 31MM MASTERS VALVE. A 29MM MASTERS VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8561968 ↗
• InjuryNov 15, 2018Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2018, A 31MM MASTERS VALVE WAS IMPLANTED IN THE MITRAL POSITION IN A PATIENT WITH NORMAL RIGHT VENTRICULAR FUNCTION. DURING DEVICE PREP, THE LEAFLETS OF THE VALVE WERE TESTED AND OBSERVED WITH GOOD MOBILITY. THE IMPLANT SITE WAS DEBRIDED AND AFTER SUTURING, THE PHYSICIAN OBSERVED MOVEMENT OF THE LEAFLETS WITH A LEAFLET TESTER. WHILE THE CHEST WAS OPEN, ECHOCARDIOGRAM REVEALED A BLOCKED LEAFLET. THE VALVE WAS REPOSITIONED WITH A VALVE HOLDER, BUT OBSTRUCTION WAS STILL OBSERVED. THE VALVE WAS EXPLANTED AND REPLACED WITH A SECOND 31MM MASTERS VALVE. THE EXPLANTED VALVE'S LEAFLETS WERE TESTED AGAIN AND WERE SEEN MOVING, BUT ONE OF THE LEAFLETS HAD LESS MOBILITY. POST-PROCEDURE, INSUFFICIENCY OF THE RIGHT VENTRICLE WAS OBSERVED AND THE PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). ON (B)(6) 2018 (FIVE DAYS POST-OP), THE SECOND 31MM MASTERS VALVE WAS OBSERVED WITH BLOCKED LEAFLETS, AND IT WAS EXPLANTED AND A MEDTRONIC HANCOCK TISSUE VALVE (UNKNOWN SIZE) WAS IMPLANTED. THROMBUS WAS NOTED ON THE SECOND 31MM MASTERS VALVE AND PER REPORT, THE USER BELIEVES THE FIRST VALVE WAS DUE TO THE VALVE PERFORMANCE AND THE SECOND VALVE'S OBSTRUCTION WAS DUE TO THROMBUS FROM T

  Patient problems: Thrombus

  MAUDE report 8073994 ↗
• InjuryNov 8, 2018Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2018, A 31MM MASTERS VALVE WAS IMPLANTED IN THE MITRAL POSITION. DURING DEVICE PREP, THE LEAFLETS OF THE VALVE WERE ABLE TO MOVE; HOWEVER, FOLLOWING IMPLANTATION "PLANT", THE PHYSICIAN OBSERVED MOVEMENT OF THE LEAFLETS WITH A LEAFLET TESTER. ECHOCARDIOGRAM AFTER PROCEDURE REVEALED A BLOCKED LEAFLET. THE VALVE WAS REPOSITIONED, BUT OBSTRUCTION WAS STILL OBSERVED. THE VALVE WAS EXPLANTED AND REPLACED WITH A SECOND 31MM MASTERS VALVE. THE EXPLANTED VALVE'S LEAFLETS WERE TESTED AGAIN AND WERE SEEN MOVING, BUT ONE OF THE LEAFLETS HAD LESS MOBILITY. POST-PROCEDURE, INSUFFICIENCY OF THE RIGHT VENTRICLE WAS OBSERVED SO THE PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). ON (B)(6) 2018, THE SECOND 31MM MASTERS VALVE WAS OBSERVED WITH BLOCKED LEAFLETS. THE SECOND 31MM MASTERS VALVE WAS EXPLANTED AND A HANCOOK TISSUE VALVE (UNKNOWN SIZE) WAS IMPLANTED. THROMBUS WAS NOTED ON THE SECOND 31MM MASTERS VALVE. PER REPORT, THE USER BELIEVES THE FIRST VALVE WAS DUE TO PRODUCT PERFORMANCE WHILE THE SECOND VALVE'S OBSTRUCTION WAS DUE TO THROMBUS FROM THE EFFECTS OF ECMO.

  Patient problems: Thrombus

  MAUDE report 8050777 ↗