Masters Series™ 23CAVGJ-514 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067044075), received between Jul 26, 2024 and Mar 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 23MM MASTERS MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION, THE LEAFLETS WERE NOT MOVING NORMALLY WHEN TESTED WITH A VALVE SIZER. DURING IMPLANT, VALVE INSUFFICIENCY WAS OBSERVED; THE VALVE WAS UNABLE TO OPEN AND CLOSE. THE VALVE WAS REMOVED AND LEAFLET FUNCTION WAS TESTED OUTSIDE OF THE PATIENT, BUT THE ISSUE PERSISTED. A NEW 23MM MASTERS MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635166 ↗
• MalfunctionNov 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM MASTERS VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THERE WAS POOR OPENING AND CLOSING OF THE VALVE LEAFLETS. THE VALVE WAS REPLACED WITH A 25MM MASTERS TO RESOLVE THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE VALVE LEAFLETS WERE NOTED TO HAVE BEEN MOVING NORMALLY DURING DEVICE PREP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652847 ↗
• MalfunctionJul 26, 2024Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 23MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS CHOSEN FOR A PROCEDURE. THE VALVE GRAFT APPEARED NORMAL DURING PREPARATION. DURING PROCEDURE, THE SURGEON FOUND LARGE AMOUNT OF YELLOW DOTS INSIDE THE CONDUIT. THE CONDUIT WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO REPORT ANY ADVERSE EVENT. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844725 ↗