Masters Series™ 25CAVGJ-514 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067044099), received between Mar 4, 2024 and Mar 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionMar 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION, THE LEAFLETS WERE MOVING NORMALLY. AFTER THE VALVE WAS IMPLANTED AND SUTURING WAS COMPLETED, THE HEART STARTED BEATING AGAIN. HOWEVER, THIS WAS "ACCOMPANIED BY THE PROBLEM OF BLOCKING THE HEART VALVE." THE VALVE WAS UNABLE TO BE ROTATED AFTER IMPLANTATION; THE LEAFLETS WERE NOT OPENING AND CLOSING. THE CAUSE OF THE INABILITY TO ROTATE WAS REPORTED AS "THE MECHANICAL VALVE IS STUCK." A VALVE MEASURING DEVICE WAS USED TO TEST THE LEAFLET FUNCTION. THE VALVE WAS EXPLANTED AND UPON EXPLANT, THE LEAFLET MOVEMENT WAS TESTED AGAIN WITH NORMAL MOBILITY. IT WAS EXCHANGED FOR A NEW 23MM MASTERS SERIES HEART COATED AORTIC VALVED GRAFT, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635063 ↗
• MalfunctionDec 13, 2024Contamination /Decontamination Problem; Physical Resistance/Sticking; Contamination /Decontamination Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE SUTURING THE VALVE, THE PHYSICIAN NOTICED STAINS ON THE AORTIC VALVE GRAFT TUBE. THE DEVICE WAS REMOVED AND REPLACED. IT WAS ALSO NOTED THAT THE LEAFLETS DIDN'T OPEN AND CLOSE SMOOTHLY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929042 ↗
• MalfunctionMar 4, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6)2024, A 25MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS CHOSEN FOR A BENTALL PROCEDURE. DURING PROCEDURE, AFTER THE ANASTOMOSIS OF THE DEVICE, THE PHYSICIAN FOUND LARGE AMOUNT OF YELLOW DOTS INSIDE THE CONDUIT. THERE WAS NO ANOMALIES WERE FOUND DURING PREPARATION. THE PHYSICIAN DECIDED NOT TO EXPLANT THE DEVICE AND TRIED TO REMOVE THEM ONE BY ONE. WHEN THE BLOOD FLOW WAS RESTORED HE REPORTED A LOST OF IMPERMEABILITY OF THE CONDUIT, THE INITIAL LOSS OF BLOOD FROM THE TISSUE WAS RESOLVED AFTER SOME MINUTES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828841 ↗