SJM™ Masters Series 29MECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05414734006545), received between Jun 20, 2018 and Mar 22, 2023 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS CHOSEN FOR IMPLANT. WHILE ATTEMPTING TO IMPLANT THE VALVE, THE LEAFLET OF THE VALVE WAS BROKEN. A NEW 29MM EPIC VALVE WAS THEN SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594701 ↗
• InjuryNov 7, 2022Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2022 A 29MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED SUCCESSFULLY. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED A SEVERE PARAVALVULAR LEAK. IT WAS NOTED THAT DURING THE SAME TIME THE PATIENT HAD JAUNDICE, UNRELATED TO THE PARAVALVULAR LEAK, THAT RESOLVED AFTER TREATMENT. THE VALVE WAS EXPLANTED (B)(6) 2022 AND REPLACED WITH A NEW 29MM SJM MASTERS SERIES VALVE EXPANDED CUFF. IT WAS NOTED THAT THE PATIENT EXPERIENCED PULMONARY HYPERTENSION DURING SURGERY. THE PATIENT IS REPORTED TO BE STABLE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 15750063 ↗
• InjuryDec 21, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, A 29MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED. IN (B)(6) 2021, PROSTHETIC VALVE THROMBOSIS WAS DIAGNOSED AND THE PATIENT WAS TREATED WITH THROMBOLYTIC THERAPY. THE PATIENT WAS REPORTED TO HAVE RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13056344 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 29MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED. POST-PROCEDURE, AFTER THE PATIENT WAS CLOSED, A LARGE AMOUNT OF BLOOD WAS DRAINED AND VENTRICULAR RUPTURE WAS OBSERVED. AS A RESULT, THE MASTERS VALVE WAS EXPLANTED. THE USER ALLEGED THAT INJURY TO THE MYOCARDIUM BY A NON-ABBOTT DEVICE WAS THE CAUSE OF THE VENTRICULAR RUPTURE. A NEW 27MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO CLINICALLY SIGNIFICANT PROLONGED PROCEDURE TIME WAS REPORTED. THE PATENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857201 ↗
• InjuryJul 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 29MM SJM MASTERS MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. AFTER THE VALVE WAS FIXATED IN THE MITRAL RING, THE PHYSICIAN WAS APPLYING A ROTATION WITH THE VALVE ONTO THE VALVE HOLDER WHEN A LEAFLET CAME OUT OF ITS' HOUSING. THE PHYSICIAN SECURED THE VALVE TO THE PATIENT'S MITRAL ANNULUS WITH NON-ABBOTT COR-KNOTS, HOWEVER THE VALVE HAD TO BE REMOVED AND A NEW 29MM SJM MASTERS MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT THE PATIENT WAS NOT HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. ADDITIONALLY, THE PROCEDURES WAS REPORTED TO HAVE BEEN DELAYED FOR APPROXIMATELY 30 MINUTES IN EXTRACORPOREAL CIRCULATION. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12153495 ↗
• MalfunctionOct 22, 2020Fracture; Material Separation; Improper or Incorrect Procedure or Method; Fracture; Material Separation; Improper or Incorrect Procedure or Method

  ON (B)(6) 2020, A 29MM SJM MASTERS SERIES VALVE EXPANDED CUFF (SERIAL#: (B)(4)) WAS SELECTED FOR IMPLANT IN THE PATIENT. DURING THE MITRAL VALVE REPLACEMENT, THE VALVE WAS IMPLANTED AND SUTURED. WHEN THE PHYSICIAN ATTEMPTED TO ROTATE THE VALVE USING THE HOLDER, A CLICK WAS HEARD AND ONE OF THE LEAFLETS POPPED OUT. THE PHYSICIAN TRIED TO FORCE THE LEAFLET IN AND THE LEAFLET BROKE INTO PIECES. ALL OF THE PIECES WERE FISHED OUT OF THE PATIENT AND THE VALVE WAS EXPLANTED. AFTER THE VALVE WAS EXPLANTED, A NEW VALVE WAS SOURCED FROM A NEARBY HOSPITAL AND A NEW 29MM SJM MASTERS SERIES VALVE EXPANDED CUFF( SERIAL#1: (B)(4)) WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS ON CARDIAC BYPASS FOR AN EXTENDED TIME, AS THE PROCEDURE WAS EXTENDED BY AN HOUR. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, THERE WERE NO SERIOUS INJURIES AND THE PATIENT WAS DISCHARGED FROM THE ICU 3 DAYS LATER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10718552 ↗
• MalfunctionApr 20, 2020Fracture; Fracture

  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: 2648612-2020-00037.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9976894 ↗
• InjuryJun 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019, A 29MM MASTERS VALVE WAS SELECTED FOR IMPLANT. DURING AN INTERNAL ROTATION OF THE VALVE, WHILE THE DEVICE WAS ATTACHED WITH SUTURES, THE VALVE BROKE. THE DEVICE WAS EXCHANGED FOR ANOTHER SIZE AND IMPLANTED, DOUBLING THE PROCEDURE AND EXTRA CORPORAL CIRCULATION TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8733043 ↗
• InjuryJun 21, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2019, 29MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS SELECTED FOR IMPLANT AND AFTER IMPLANTING THE VALVE, ONE OF THE LEAFLETS WERE OBSTRUCTED. THE PHYSICIAN ATTEMPTED TO ROTATE THE VALVE WHICH LEAD TO THE LEAFLET TO BREAK AND CAUSED EXTENDED PROCEDURE TIME. THE VALVE WAS EXCHANGED FOR A 27MM SJM MASTERS SERIES VALVE EXPANDED CUFF. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8722046 ↗
• InjuryDec 4, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2018, A PATIENT WITH BARLOW¿S DISEASE UNDERWENT A REDO MVR DUE TO LEAKAGE. THE ORIGINAL MITRAL VALVE PROSTHESIS WAS EXPLANTED AND A 29MM MASTERS VALVE WAS IMPLANTED IN THE MITRAL POSITION. ON POST-OPERATIVE DAY 1, THE PATIENT HAD CORONARY STENT THROMBOSIS CONFIRMED ON ECHOCARDIOGRAM, RADIO IMAGING AND CT SCAN, AND THE PHYSICIAN ELECTED TO DO A CIRCUMFLEX CORONARY BYPASS. HEPARIN WAS ALSO ADMINISTERED, AND AFTER THREE DAYS ON ANTICOAGULANTS, THE PATIENT ¿S INR WAS INITIALLY TOO LOW, THEN IT INCREASED AND WAS TOO HIGH. ON (B)(6) 2018, INCREASED MITRAL GRADIENT WAS OBSERVED, AND A SCAN REVEALED MITRAL THROMBOSIS. ON (B)(6) 2018, THE MASTERS VALVE WAS EXPLANTED AND REPLACED WITH A 29MM EDWARDS PERIMOUNT VALVE. UPON EXPLANT, NO ENDOCARDITIS WAS REPORTED. THE PATIENT WAS REPORTED TO BE RECOVERING.

  Patient problems: Mitral Valve Stenosis; Thrombus

  MAUDE report 8131271 ↗
• InjuryJun 20, 2018Fracture; Fracture

  ON (B)(6) 2018, A 29MM MASTERS SERIES VALVE WAS CHOSEN FOR IMPLANT IN THE MITRAL POSITION. WHEN THE PHYSICIAN WAS SUTURING THE VALVE IN PLACE, A LEAFLET BROKE IN TWO PIECES. ANOTHER 29MM MASTERS SERIES VALVE WAS IMPLANTED. ALTHOUGH THE PROCEDURE WAS EXTENDED BY 30-45 MINUTES, NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7623057 ↗