Masters Series™ 23AJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067043030), received between Mar 18, 2025 and Jun 30, 2025 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM MASTERS VALVE WAS SUCCESSFULLY IMPLANTED. AFTER THE HEART RESUMED BEATING, AN ESOPHAGEAL ULTRASOUND WAS PERFORMED AND THE TRANSVALVULAR PRESSURE DIFFERENCE WAS TOO HIGH AND THE BLOOD FLOW VELOCITY WAS TOO FAST. THE MECHANICAL VALVE WAS REMOVED AND TESTED, REVEALING THAT THE VALVE LEAFLETS WERE HAVING DIFFICULTY OPENING AND CLOSING. A NEW 19MM REGENT VALVE WAS IMPLANTED TO RESOLVE THE EVENT. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS DOING WELL.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22359634 ↗
• MalfunctionMar 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM MASTERS AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION, THE LEAFLETS WERE NOT MOVING NORMALLY WHEN TESTED WITH A VALVE TESTER. DURING PROCEDURE, THE VALVE LEAFLETS DID NOT "OPEN AND CLOSE FLEXIBLY" AND WAS REMOVED. UPON REMOVAL, THE LEAFLETS WERE AGAIN TESTED OUTSIDE OF THE PATIENT AND THE ISSUE PERSISTED. A NEW 23MM MASTERS AORTIC MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN NORMAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635165 ↗