Masters Series™ 27MECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067045232), received between Sep 10, 2024 and Jul 17, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionJul 17, 2026Fracture; Physical Resistance/Sticking

  It was reported that on (b)(6) 2026, a 27mm SJM Masters Series Valve Expanded Cuff was chosen for a procedure. While rotating the valve a moderate resistance was felt. During the procedure, after the valve implant when they rotated the valve both leaflets popped out. They confirmed both leaflets were recovered. They explanted it and replaced with a new 27mm SJM Masters Series Valve Expanded Cuff. There was some delay occurred from excising first valve and placing second valve. The patient was reported in post operative recovery course.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25855383 ↗
• MalfunctionMar 30, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 27MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE VALVE FELL APART BEFORE BEING IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717953 ↗
• InjurySep 10, 2024Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT IN 2008, A 27MM MASTERS VALVE WAS SELECTED FOR IMPLANT. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE VALVE WAS NOTED TO HAVE PARAVALVULAR LEAK AND THE PATIENT WAS DIAGNOSED WITH ENDOCARDITIS. ON (B)(6) 2024, A 14X5MM AMPLATZER VASCULAR PLUG III WAS SELECTED FOR IMPLANT TO TREAT THE MITRAL PARAVALVULAR LEAK. THE LEAK WAS DIFFICULT TO ACCESS DUE TO THE SEPTAL POSITION. THE EXACT SIZE OF THE LEAK WAS DIFFICULT TO ASSESS BUT BASED ON THE JET WIDTH AND LENGTH, THE LEAK WAS CONSIDERED AS SEVERE. THE AMPLATZER DEVICE WAS THEN DEPLOYED AND RELEASED. FOLLOWING THE DEVICE RELEASE, THE TEE EXAM SHOWED AN UNEXPECTED MODERATE LEAK NEXT TO THE DEVICE AT 12:00PM (AORTIC SIDE). THE PHYSICIAN TRIED TO CROSS THE REMAINING LEAK IN PREPARATION FOR A SECOND DEVICE BUT GIVEN THE COMPLEXITY DECIDED TO STOP THE PROCEDURE AND WILL FOLLOW THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Dyspnea; Endocarditis; Insufficient Information

  MAUDE report 20180560 ↗