Masters Series™ 33MECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067045294), received between May 23, 2025 and Feb 5, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incomplete Coaptation” (2 reports).

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.

• InjuryFeb 5, 2026Incomplete Coaptation; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (b)(6) 2026, A 33MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED IN THE PATIENT. TWENTY FOUR HOURS LATER, PATIENT NEEDED MORE INOTROPES AND A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED A THROMBUS WAS BUILT ON THE VALVE. INTRAOPERATIVELY, THE PATIENT WAS HEMODYNAMICALLY STABLE AND DRY, WITH NO VISIBLE BLEEDING. HOWEVER, IN THE INTENSIVE CARE UNIT, DUE TO INCREASED CHEST TUBE DRAINAGE OUTPUT, MEDICATIONS WERE ADMINISTERED. THE PATIENT WAS REOPERATED THE NEXT DAY BECAUSE ONE LEAFLET WAS NOT MOVING. THE PATIENT WAS REPORTED RECOVERED.

  Patient problems: Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus

  MAUDE report 24272476 ↗
• InjuryJan 16, 2026Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 33MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS CHOSEN FOR A PROCEDURE. POST OPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) SHOWED REGURGITATION. THE ANTERIOR LEAFLET WAS NOT FUNCTIONING PROPERLY. THE PATIENT RETURNED TO THEATRE FOR UNPLANNED SURGERY TO REPLACE WITH A FUNCTIONING VALVE. THE PATIENT WAS IN LOW CARDIAC OUTPUT STATE OVERNIGHT ON DAY 0 POST OPERATIVELY, CONFOUNDED BY ASPIRATION EVENT. THE PATIENT SUFFERED A PERIOD OF LOW CARDIAC OUTPUT WITH RESULTANT MULTI ORGAN FAILURE. ON 18 JAN 2026, THE PATIENT WAS REPORTED PASSED AWAY FROM NEUROLOGICAL INJURY, MULTI ORGAN FAILURE, GASTROINTESTINAL ISCHEMIA/INFRACTION AND UPPER GASTROINTESTINAL (GI) BLEEDING.

  Patient problems: Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24093020 ↗
• MalfunctionMay 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: THE VALVE FUNCTIONED NORMALLY WHEN TESTED DURING PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078611 ↗