SJM™ Masters Series 31MECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734006613), received between Aug 27, 2018 and Sep 19, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2022Incomplete Coaptation; Patient-Device Incompatibility; Physical Resistance/Sticking; Incomplete Coaptation; Patient-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM SJM REGENT HEART VALVE (30267042) WAS IMPLANTED IN THE AORTIC VALVE AND A 31MM SJM MASTERS SERIES VALVE EXPANDED CUFF (30513648) WAS IMPLANTED IN THE MITRAL VALVE DURING A DOUBLE VALVE REPLACEMENT. ON A LATER DATE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND SYNCOPAL EPISODES. THE AORTIC VALVE AND MITRAL VALVE WERE BOTH EXPERIENCING RESISTANCE OR STICKING. ON (B)(6) 2022, ANOTHER DOUBLE VALVE REPLACEMENT WAS PERFORMED. FOR THE AORTIC VALVE, THE 23MM SJM REGENT HEART VALVE (30267042) WAS EXPLANTED AND REPLACED WITH A 21MM SJM REGENT HEART VALVE (30866094). FOR THE MITRAL VALVE, THE 31MM SJM MASTERS SERIES VALVE EXPANDED CUFF (30513648) WAS EXPLANTED AND REPLACED WITH A 31MM SJM MASTERS SERIES VALVE EXPANDED CUFF (30627400). THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation; Syncope/Fainting

  MAUDE report 15451388 ↗
• MalfunctionJul 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2021, A 31 MM ST. JUDE MEDICAL (SJM) MASTERS SERIES VALVE EXPANDED CUFF WAS CHOSEN FOR IMPLANT. AFTER THE VALVE WAS IMPLANTED AND DURING THE PROCESS OF LEAFLET TESTING FOR MOVEMENT, IT WAS OBSERVED THAT ONE OF THE LEAFLETS ON THE VALVE WAS NOT MOVING. THE VALVE WAS EXPLANTED. AFTER THE VALVE WAS NO LONGER WITHIN THE ANNULUS, THE USER TESTED THE LEAFLETS AND NOTED THAT ONLY ONE LEAFLET WAS MOVING SLIGHTLY AFTER IT WAS EXPLANTED. A NEW 29 MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS SUCCESSFULLY IMPLANTED INSTEAD. THE PATIENT WAS ON CARDIOPULMONARY BYPASS (CPB) FOR 95 MINUTES LONGER THAN CONVENTIONAL DUE TO THIS EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193239 ↗
• InjuryDec 11, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2020, A 31MM MASTERS SERIES VALVE EXPANDED CUFF WAS SELECTED FOR IMPLANT IN THE PATIENT. PRIOR TO THE PROCEDURE THE LEAFLETS WERE CHECKED MULTIPLE TIMES USING A Q-TIP, BUT ONCE THE DEVICE WAS IMPLANTED ONE LEAFLET WOULD NOT OPEN. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE LEAFLETS APPEARED TO OPEN AND CLOSE NORMALLY OUTSIDE THE ANNULUS. A 33MM MEDTRONIC HANCOCK TISSUE MITRAL VALVE WAS IMPLANTED INSTEAD AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID EXPERIENCE A LOW OUTPUT SYNDROME FROM THE 3 AORTIC CROSS CLAMPS DURING THE PROCEDURE.

  Patient problems: Low Cardiac Output; Occlusion

  MAUDE report 10992634 ↗
• InjuryMar 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020, THE PHYSICIAN SELECTED A 31MM MASTERS VALVE TO IMPLANT. FOR AN UNKNOWN REASON, THE 31MM MASTERS VALVE WAS IMPLANTED THEN EXPLANTED AND EXCHANGED FOR A 27MM MECHANICAL VALVE (SN (B)(4)). THE 27MM VALVE DROPPED DUE TO POOR COORDINATION. ANOTHER 27MM VALVE (SN (B)(4)) WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9800714 ↗
• InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A 31MM MASTERS VALVE WAS SELECTED FOR IMPLANT. THE DEVICE WAS IMPLANTED BUT SEVERE MITRAL REGURGITATION WAS OBSERVED VIA TEE. THE PATIENT WAS PLACED BACK ON BYPASS. THE VALVE WAS INSPECTED AND CONFIRMED THERE WAS NO SUBVALVULAR OBSTRUCTION OR ANY HINDRANCES TO THE LEAFLETS. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY WITH A 31MM CARBOMEDICS MECHANICAL HEART VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DESPITE THE BYPASS TIME BEING PROLONGED BY 90 MINUTES.

  Patient problems: Mitral Regurgitation

  MAUDE report 8463914 ↗
• InjuryAug 27, 2018Obstruction of Flow; Device Dislodged or Dislocated; Obstruction of Flow; Device Dislodged or Dislocated

  ON (B)(6) 2018, A 31MM MASTERS SERIES MITRAL VALVE ((B)(4)) AND 23MM MASTERS SERIES AORTIC VALVE ((B)(4)) WERE IMPLANTED DURING A CONCOMITANT MVR AND AVR PROCEDURE. A LEAFLET TESTER WAS USED TO TEST FUNCTION OF THE LEAFLETS. WHILE WEANING THE PATIENT FROM CARDIOPULMONARY BYPASS, THE PA PRESSURE WAS NOTED TO BE VERY LOW. THE LEFT ATRIUM WAS REOPENED AND ONE LEAFLET FROM THE MITRAL VALVE WAS NOTED TO BE DISLODGED FROM THE BUTTERFLY HINGE AND HAD OBSTRUCTING BOTH LEAFLETS. THE MITRAL VALVE WAS EXPLANTED AND A SECOND 31MM MASTERS SERIES MITRAL VALVE WAS IMPLANTED. THE PATIENT IS REPORTED TO BE STABLE AND HAS MOVED TO THE ICU WITH ALL THE PARAMETERS WITHIN NORMAL RANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7820632 ↗