SJM™ Masters Series 23MTJ-503Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734053600), received between Aug 18, 2025 and Aug 18, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2025Patient Device Interaction Problem; Physical Resistance/Sticking; Patient Device Interaction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM MASTERS SERIES HEART VALVE WITH EXPANDED TEFLON WAS IMPLANTED. THE LEAFLETS WERE FUNCTIONING NORMALLY UNTIL EARLY (B)(6) 2025. ON (B)(6) 2025, THERE WAS "CONCERN THAT THE VALVE MAY HAVE BECOME STUCK." ECHOCARDIOGRAPHY WAS PERFORMED WHICH SHOWED STUCK LEAFLETS. THROMBUS HAD ACCUMULATED AT THE PIVOT AND THE VALVE WAS EXPLANTED. UPON EXPLANT, LEAFLET FUNCTION WAS TESTED AND "WERE STUCK DUE TO MATERIAL ADHERED TO THE PIVOT." A NEW 25MM NON-ABBOTT DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22833926 ↗