SJM™ Masters Series 27MTJ-503Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734053624), received between Sep 25, 2018 and Apr 6, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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.

• MalfunctionApr 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM SJM MASTERS SERIES HEART VALVE WITH TEFLON CUFF WAS CHOSEN FOR PROCEDURE. DURING THE PROCEDURE, THE VALVE WAS REMOVED DUE TO THE SIZE DIFFERENCE AND THERE WAS DIFFICULTY PARACHUTING THE DEVICE INTO THE ANNULUS. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT VALVE AS A REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691288 ↗
• InjurySep 25, 2018Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A MITRAL VALVE REPLACEMENT (MVR) WAS PERFORMED AND THIS 27MM MASTERS SERIES HEART VALVE WAS IMPLANTED. CONCOMITANTLY, A TRICUSPID ANNULOPLASTY (TAP) AND MAZE PROCEDURE WERE PERFORMED. WHEN RETURNING TO SPONTANEOUS CIRCULATION, THE PATIENT'S LEFT VENTRICLE RUPTURED. THE RUPTURED AREA OF THE LEFT VENTRICLE WAS REPAIRED AND THIS VALVE WAS EXPLANTED AND REPLACED WITH A SMALLER 25MM MASTERS SERIES HEART VALVE. THE PATIENT HAS BEEN IN STABLE CONDITION POSTOPERATIVELY. THE SURGEON ASSUMED THAT DUE TO OVER SIZING OF THIS VALVE AGAINST THE PATIENT'S MITRAL ANNULUS, THE PATIENT'S MYOCARDIUM WAS LIKELY PERFORATED/TORN BY THE PIVOT GUARD OF THIS VALVE, WHICH RESULTED IN RUPTURE OF LEFT VENTRICLE. THIS VALVE WAS DISCARDED IN THE HOSPITAL AND WILL NO LONGER BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION IS EXPECTED.

  Patient problems: Cardiac Perforation; Tissue Damage

  MAUDE report 7908238 ↗