SJM™ Masters Series AJ-501 (REF 25AJ-501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734021128), received between Nov 27, 2019 and Oct 25, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2021Biocompatibility; Physical Resistance/Sticking; Biocompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT A 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED ON (B)(6) 2021. POST PROCEDURE, THE VALVE LEAFLETS COULD NOT OPEN AND CLOSE NORMALLY AFTER IMPLANT RELATED TO THROMBOSIS. IT WAS NOTED THAT THE PATIENT HAS HAD A PREVIOUS STROKE AND INSUFFICIENT ANTICOAGULATION. THERE WAS NO PATIENT ANATOMY INTERFERENCE THAT COULD HAVE CAUSED THE INCOMPLETE COAPTATION. IT WAS REPORTED THAT THERE WAS SOME ABNORMALITIES WITH THE VALVE BUT DETAILS WERE NOT PROVIDED. DEVICE WAS REPLACED WITH A NEW 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE THAT WAS IMPLANTED ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT DID NOT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12691401 ↗
• InjurySep 8, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED ON (B)(6) 2021, A 25MM AORTIC SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED IN THE MITRAL POSITION. THE PHYSICIAN HAD INTENDED TO IMPLANT A 25MM MITRAL SJM MASTERS SERIES MECHANICAL HEART VALVE. WHEN THE VALVE WAS IMPLANTED IN THE MITRAL POSITION AND THE PATIENT WAS TAKEN OFF BYPASS, IT WAS NOTED THAT THE PATIENT'S HEART WAS NOT BEATING PROPERLY. AFTER FURTHER DIAGNOSIS AND CONFIRMATION, IT WAS DETERMINED THAT THE IMPLANTED VALVE WAS A 25MM AORTIC SJM MASTERS SERIES MECHANICAL HEART VALVE. THE INCORRECT AORTIC SJM MASTERS SERIES MECHANICAL HEART VALVE WAS EXPLANTED AND REPLACED WITH A NEW 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE DUE TO THE INCORRECT VALVE BEING IMPLANTED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION AND IS BEING MONITORED. ADDITIONAL INFORMATION IS PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439258 ↗
• InjuryNov 27, 2019Perivalvular Leak; Perivalvular Leak

  ON AN UNKNOWN DATE, A 25MM MASTERS MECHANICAL HEART VALVE WAS IMPLANTED. ON (B)(6) 2017, DURING HOSPITAL FOLLOW UP, THE PATIENT HAD SUSPECTED PARAVALVULAR LEAKAGE AND SECONDARY SURGERY WAS PERFORMED TO REPAIR THE PARAVALVULAR LEAK. THE PATIENT WAS STABLE. ON (B)(6) 2017, DURING HOSPITAL FOLLOW UP, THE PATIENT PASSED AWAY DUE TO CARDIAC FAILURE, MITRAL INSUFFICIENCY, AND TRICUSPID INSUFFICIENCY. THE VALVE REMAINS IMPLANTED.

  Patient problems: Congestive Heart Failure; Mitral Insufficiency; Tricuspid Insufficiency

  MAUDE report 9385397 ↗