SJM™ Masters Series AJ-501 (REF 23AJ-501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734021111), received between Jul 3, 2019 and Feb 21, 2023 — classified as 2 deaths, 3 injuries, 1 malfunction.

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

• InjuryFeb 21, 2023Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANT. THE VALVE WAS IMPLANTED, AND THE OPERATION WAS CONCLUDED. IMMEDIATELY AFTER, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED REGURGITATION. THE VALVE WAS EXPLANTED AND A 23MM SJM REGENT HEART VALVE WAS IMPLANTED AS A REPLACEMENT. AFTER THE VALVE WAS EXPLANTED, THERE WAS NO PROBLEMS SEEN WITH THE VALVE ITSELF. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16414293 ↗
• DeathOct 26, 2022Perivalvular Leak; Perivalvular Leak

  THE JOURNAL, "58TH ANNUAL MEETING OF JAPANESE SOCIETY OF PEDIATRIC CARDIOLOGY AND CARDIAC SURGERY CONFERENCE" , WAS REVIEWED. THIS ARTICLE REPORTED A CASE STUDY OF A 41 YEAR OLD PATIENT WHO WAS IMPLANTED WITH A 23MM SJM MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED AT THE AGE OF 10 YEARS OLD. THE PATIENT AT THE AGE OF 5 HAD UNDERWENT A COMMISSUROTOMY DUE TO AORTIC STENOSIS AND REGURGITATION. IT WAS NOTED THAT THE PATIENT HAD BEEN PRESCRIBED A REGIMEN OF CARVEDILOL AND ENALAPRIL MALEATE FOR DECLINING CARDIAC FUNCTION AND MILD TRANS-VALVULAR LEAKAGE. THE PATIENT HAD A LEFT VENTRICULAR EJECTION FRACTION OF 40% AND THEIR CONDITION WAS STABLE, WITH A NEW YORK HEART ASSOCIATION GRADE OF 2. ON AN UNKNOWN DATE THE PATIENT WAS HOSPITALIZED DUE TO ACUTE HEART DECOMPENSATION, A CALCIFIED VENTRICULAR SEPTAL DEFECT PATCH, AND A PERIVALVULAR LEAK (PVL) AT THE STITCH SITE OF THE MECHANICAL HEART VALVE, ALL DETECTED VIA ECHOCARDIOGRAM. THE PATIENT WAS ADDITIONALLY PRESCRIBED TOLVAPTAN AND ENALAPRIL MALEATE WAS REPLACED WITH AN ANGIOTENSIN RECEPTOR-NEPRILYSIN INHIBITOR. THE PATIENT'S CONDITION IMPROVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 2 WEEKS LATER. HOWEVER, IT WAS NOTED THAT 9

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 15671690 ↗
• InjuryJan 5, 2022Backflow; Backflow

  IT WAS REPORTED THAT ON (B)(6) 2021, THAT A 23 MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR AN AORTIC VALVE REPLACEMENT SURGERY FOR A PATIENT WITH COMORBIDITY OF GRADE II DIABETES. DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE VALVE HAD GOOD ACTIVITY BY INTRAOPERATIVE ESOPHAGEAL ULTRASOUND, BUT THERE WAS GRADE 4 REFLUX BETWEEN THE TWO VALVE LEAFLETS DUE TO THE VALVE NOT SEALING COMPLETELY. THE PATIENT WAS PLACED BACK ONTO BYPASS, THE VALVE WAS REMOVED, AND REPLACED WITH ANOTHER 23 MM SJM MASTERS SERIES MECHANICAL HEART VALVE TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PHYSICIAN SPECULATED THAT THIS ISSUE MAY BE CAUSED BY THE MECHANICS OF THE MECHANICAL VALVE. THE PATIENT IS RECOVERING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 13168689 ↗
• MalfunctionMar 4, 2020Material Separation; Material Separation

  ON (B)(6) 2020 A SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR THE PROCEDURE. THE PHYSICIAN REPORTED DURING THE PROCEDURE, THE DEVICE WAS IMPLANTED AND THE USER NOTICED THE LEAFLET DETACHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 2/24 PM.

  Patient problems: Mitral Insufficiency

  MAUDE report 9785874 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH A 23MM MASTERS VALVE DUE TO INFECTIVE ENDOCARDITIS AND AORTIC VALVE INSUFFICIENCY. ON (B)(6) 2018, DURING A CLINICAL FOLLOW-UP, IT WAS IDENTIFIED THAT THE PATIENT HAD A CEREBRAL HEMORRHAGE AND CEREBRAL INFARCTION RESULTING IN LOWER LIMB PARALYSIS. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Hemorrhage, Cerebral; Infarction, Cerebral; Paralysis

  MAUDE report 9347899 ↗
• DeathJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A 23MM MASTERS VALVE WAS IMPLANTED. ON (B)(6) 2019, THE PATIENT WAS REPORTED TO HAVE EXPIRED DUE TO AN UNKNOWN CAUSE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Death

  MAUDE report 8761022 ↗