SJM™ Masters Series 25MTJ-503Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734053617), received between Sep 11, 2018 and Apr 7, 2023 — classified as 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2018, A 25MM SJM MASTERS SERIES HEART VALVE WITH TEFLON CUFF WAS SUCCESSFUL IMPLANTED. ON (B)(6) 2023, THE PATIENT PRESENTED WITH INFECTIVE ENDOCARDITIS AND A RE-DO PROCEDURE WAS PERFORMED. THERE WAS NO PARTICULAR PROBLEM DUE TO IT BEING A MECHANICAL VALVE, BUT REOPERATION WAS PERFORMED BECAUSE OF PARA-VALVULAR LEAK. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER 25MM SJM MASTERS SERIES HEART VALVE WITH TEFLON CUFF. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A FEVER DUE TO THE INFECTIVE ENDOCARDITIS. THE PATIENT DOES NOT HAVE ANY HISTORY OF ENDOCARDITIS. THE PATIENT DOES NOT HAVE A HISTORY AN INDWELLING VASCULAR CATHETER, INTRAVENOUS DRUG USE, RECENT DENTAL WORK, OR INJURY FROM A NON-STERILE OBJECT. THE PARAVALVULAR LEAK IS BELIEVED TO HAVE BEEN A RESULT OF THE INFECTIVE ENDOCARDITIS. THE IMPLANTING PHYSICIAN BELIEVES THAT THE CAUSE OF THE ENDOCARDITIS IS DUE TO A PATIENT CONDITION. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: Endocarditis; Fever

  MAUDE report 16704681 ↗
• MalfunctionJun 26, 2020Backflow; Biocompatibility; Backflow; Biocompatibility

  ON (B)(6) 2019 A SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF WAS IMPLANTED IN THE DIABETIC AND DIALYSIS PATIENT, A SUPRA-ANNULAR POSITION USING NON-EVERTING MATTRESS SUTURE TECHNIQUE WITH THE PLEDGETS ON THE OUTFLOW SIDE. AN ABBOTT SIZER (MODEL#: 905) WAS USED IN THE SURGERY. IT WAS CONFIRMED BY THE X-RAY FLUOROSCOPY DURING A FOLLOW-UP THAT ONE OF THE LEAFLETS ON THE VALVE WAS NOT MOVING, AND ON (B)(6) 2020, A RE-DO AVR WAS PERFORMED. THE 25MM SJM MASTER SERIES HEART VALVE W/ TEFLON CUFF WAS EXPLANTED AND REPLACED WITH A 23MM SJM MASTER SERIES HEART VALVE W/TEFLON CUFF (SERIAL # (B)(4)) . UPON EXPLANT OF THE VALVE, THROMBUS WAS CONFIRMED TO BE ADHERED AT THE PIVOT GUARD HINGE, IMPEDING THE LEAFLET MOBILITY. IT WAS REPORTED THAT INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME (INR) WAS MAINTAINED AT 2.1 BEFORE THE RE-DO AVR, AND THE PATIENT HAS HAD BEEN ADMINISTERED ANTICOAGULANTS. THE PATHOLOGICAL EXAMINATION CONCLUDED THAT THE ISSUE WAS DUE TO THROMBUS, BUT THE SURGEON REQUESTED PANNUS FORMATION ON THE VALVE, ALSO.

  Patient problems: Thrombus

  MAUDE report 10201349 ↗
• InjurySep 11, 2018Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2016, A 25MM MASTERS HEART VALVE WAS IMPLANTED IN THE MITRAL POSITION. ON (B)(6) 2018, A RE-DO MVR WAS PERFORMED DUE TO PERIVALVULAR LEAKAGE (PVL) CAUSED BY MITRAL ANNULAR CALCIFICATION (MAC) BETWEEN THE PATIENT'S NATIVE ANNULUS AND THE MIDDLE OF THE POSTERIOR WALL. THE DEVICE WAS EXPLANTED AND REPLACED WITH A 27MM MASTERS HEART VALVE (SERIAL NUMBER UNKNOWN). THE PHYSICIAN ATTRIBUTES THE PATIENT'S DISEASE TO HAVE CAUSED THIS EVENT, AND NOT RELATED TO THE VALVE.

  Patient problems: Calcium Deposits/Calcification; Mitral Regurgitation

  MAUDE report 7864465 ↗