SJM™ Masters Series MECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734006675), received between Oct 29, 2018 and Oct 29, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2018Gradient Increase; Device Dislodged or Dislocated; Gradient Increase; Device Dislodged or Dislocated

  ON (B)(6) 2014, A 33 MM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED DUE TO SEVERE MITRAL STENOSIS AND REGURGITATION. AN ECHO PERFORMED ON (B)(6) 2014 NOTED A WELL SEATED MITRAL VALVE WITH MILD TRANSVALVULAR REGURGITATION AND SUSPICION OF A SMALL PERIVALVULAR LEAK AT THE SEPTAL EDGE. AN ECHO PERFORMED ON (B)(6) 2015, NOTED A WELL SEATED VALVE WITH NORMAL FUNCTION. AN ECHO PERFORMED ON (B)(6) 2018 NOTED A WELL SEATED VALVE; HOWEVER, THE MEAN GRADIENT ACROSS THE VALVE INCREASED TO 9 MMHG. THERE WAS MILD MITRAL REGURGITATION. IN THE SPRING OF 2018, THE PATIENT STARTED TO SHOW SYMPTOMS OF HEART FAILURE AND MITRAL REGURGITATION WAS PRESENT. THE PATIENT'S ANTICOAGULATION WAS INCREASED BUT THE PATIENT CONTINUED TO SUFFER FROM HEART FAILURE SYMPTOMS AND THE MITRAL REGURGITATION NEVER WENT AWAY. THE PATIENT NEVER HAD ENDOCARDITIS AND THE CAUSE OF THE REGURGITATION WAS UNKNOWN BUT THOUGHT TO BE PANNUS OVERGROWTH CAUSING OBSTRUCTION OF ONE OF THE LEAFLETS. THE PATIENT WAS ALSO FOUND TO HAVE MODERATE AORTIC STENOSIS AND REGURGITATION. DUE TO THE FAILING SYMPTOMS OF THE PATIENT, ON (B)(6) 2018, THE PATIENT WAS RE-OPERATED ON TO RE-EXPLORE THE 33 MM MASTERS SERIES MECHANICAL HEART VALVE A

  Patient problems: Heart Failure; Mitral Regurgitation

  MAUDE report 8017076 ↗