Masters Series™ 27AJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067043078), received between Jun 16, 2025 and Jan 15, 2026 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Incomplete Coaptation

  It was reported that on (b)(6)2025, a 27mm SJM Masters Series Mechanical Heart Valve was chosen for a Aortic valve replacement surgery due to severe aortic stenosis. During device preparation, the leaflets movement tested using a leaflet tester and confirmed it was moving normally. During the operation, when the valve was successfully implanted, the physician found that the valve leaflets were not opening properly due to the obstruction of tissue structure under the valve. So the Regent valve was removed and replaced by another 27mm SJM Masters Series Mechanical Heart Valve while patient on bypass. The operation was finally completed. The cardiopulmonary bypass time was prolonged, yet it did not cause any significant adverse effects. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085614 ↗
• InjuryJun 16, 2025Incomplete Coaptation; Device Stenosis; Incomplete Coaptation; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM MASTERS MECHANICAL AORTIC VALVE WAS IMPLANTED. PROCEDURE WAS UNEVENTUL. PRIOR TO DISCHARGE, A GRADIENT OF 80MMHG WAS OBSERVED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED ONE LEAFLET NOT OPENING. ON AN UNKNOWN DATE, THE VALVE WAS EXPLANTED AND A 25MM MASTER VALVE WAS USED AS REPLACEMENT. UPON FURTHER ANALYSIS OUTSIDE THE PATIENT, THE LEAFLET WAS STILL DIFFICULT TO OPEN WHEN MANUALLY MANIPULATED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22214866 ↗