SJM™ Mechanical Heart Valve M-101 (REF 25M-101)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734006323), received between Sep 23, 2019 and Feb 24, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

• InjuryFeb 24, 2020Obstruction of Flow; Obstruction of Flow

  25MM MECJ IMPLANTED ON (B)(6) 2016, PATIENT REPORTED WITH DIFFICULT IN BREATHING, ECHO ANALYSIS SHOWED THAT ONE LEAFLET HAD A RESTRICTED MOVEMENT WITH GRADIENT OF 8MMHG AND NO VALVULAR LEAK BUT THERE WAS MILD REGURGITATION. SURGEON DECIDED TO REPLACE THE VALVE AND IMPLANT A TISSUE PROSTHETIC VALVE.

  Patient problems: Mitral Regurgitation

  MAUDE report 9746973 ↗
• InjurySep 23, 2019Obstruction of Flow; Incomplete Coaptation; Obstruction of Flow; Incomplete Coaptation

  ON (B)(6) 2009, A 25MM MITRAL VALVE WAS IMPLANTED. ON (B)(6) 2019, THE PATIENT WAS HAVING DIFFICULT IN BREATHING. THE LEAFLET ON THE VALVE WAS FOUND TO BE "STUCK," IT WAS NOT MOVING FREELY AND IT WAS OBSTRUCTING. THE VALVE WAS REPLACED WITH ANOTHER 25MM MASTER MITRAL VALVE (SN: (B)(4)).

  Patient problems: Dyspnea

  MAUDE report 9107609 ↗