SJM™ Masters Series 23MECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734006170), received between Aug 31, 2020 and Jul 19, 2024 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionJul 19, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM MITRAL MASTERS VALVE WAS SELECTED FOR IMPLANT. THE VALVE WAS SIZED WITH A 905 ABBOTT SIZER SET. DURING DEVICE PREPARATION, THE LEAFLETS WERE TESTED AND MOVING NORMALLY. AFTER IMPLANT, THE VALVE LEAFLETS WERE TESTED WITH A TESTER AND THE VALVE DID NOT CLOSE COMPLETELY; THE LEAFLETS DID NOT HAVE DIFFICULTY OPENING COMPLETELY. THEREFORE, THE VALVE WAS EXPLANTED; THE PATIENT HAD NOT BEEN CLOSED PRIOR TO EXPLANTING THE VALVE. UPON EXPLANT, THE LEAFLET WAS NOT TESTED AGAIN; A NEW 25MM MITRAL MASTERS VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT'S ANTITHROMBOTIC REGIMEN CONSISTED OF HEPARIN; THE PATIENT'S LATEST INTERNATIONAL NORMALIZED RATIO (INR) AND INR HISTORY ARE UNKNOWN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784680 ↗
• InjuryOct 21, 2021Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2021, A 23 MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS SELECTED FOR IMPLANT. THE VALVE WAS IMPLANTED, HOWEVER, AS THE PHYSICIAN WENT TO ROTATE THE VALVE, A LEAFLET BROKE INTO THREE PIECES. ALL PIECES OF THE VALVE WERE CONFIRMED TO HAVE BEEN REMOVED. A NEW 21 MM EPIC AORTIC VALVE WAS SUCCESSFULLY IMPLANTED. THE USER ALLEGE A CLINICALLY SIGNIFICANT PROLONGED PROCEDURE TIME. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674432 ↗
• InjuryAug 31, 2020Gradient Increase; Obstruction of Flow; Biocompatibility; Gradient Increase; Obstruction of Flow; Biocompatibility

  ON AN UNKNOWN DATE, A (B)(6) YEAR OLD FEMALE PRESENTED TO THE HOSPITAL WITH A DIAGNOSIS OF RHEUMATIC HEART DISEASE AND SEVERE MITRAL STENOSIS. THE PATIENT UNDERWENT BALLOON MITRAL VALVOTOMY(BMV), BUT IT WAS UNSUCCESSFUL. ON (B)(6) 2019, THE PATIENT UNDERWENT EMERGENCY MITRAL VALVE REPLACEMENT AND THE MITRAL VALVE WAS REPLACED WITH A 23MM SJM MASTERS SERIES VALVE EXPANDED CUFF (SN: (B)(4)). ON (B)(6) 2020, THE PATIENT PRESENTED TO THE HOSPITAL WITH BREATHLESSNESS. HER PROTHROMBIN TIME AND INR WERE IN THERAPEUTIC RANGE(INR WAS 2.8). HOWEVER, HER ECHOCARDIOGRAPHY SHOWED A STUCK VALVE DUE TO ACUTE THROMBOSIS AND THE PATIENT UNDERWENT SUCCESSFUL THROMBOLYSIS AND THE PATIENTS ANTICOAGULATION DOSE WAS INCREASED. ON (B)(6) 2020, THE PATIENT PRESENTED WITH BREATHLESSNESS AGAIN. THE PATIENT'S PROTHROMBIN TIME WAS PROLONGED WITH PROTHROMBIN TIME TEST MORE THAN 100 SECONDS. THE ECHOCARDIOGRAPHY SHOWED AN ELEVATED MITRAL VALVE GRADIENT. FLUOROSCOPY WAS DONE AND IT SHOWED IMMOBILITY OF THE PROSTHETIC MITRAL VALVE LEAFLET. THE PATIENT UNDERWENT THROMBOLYSIS, BUT THE THROMBOLYSIS FAILED TO RELEASE THE STUCK VALVE. THE PHYSICIAN DECIDED TO PERFORM A RE-DO MITRAL VALVE REPLACEMENT. ON (B)(6) 2020, T

  Patient problems: Dyspnea; Thrombus

  MAUDE report 10473149 ↗