SJM™ Masters Series 21MECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734006057), received between Jan 28, 2021 and Jan 28, 2021 — classified as 1 death.

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

• DeathJan 28, 2021Material Separation; Material Separation

  ON (B)(6) 2020, A 21MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS SELECTED FOR IMPLANT. DURING IMPLANT, ONE OF THE LEAFLETS "POPPED OF." THE MISSING LEAFLET WAS ATTEMPTED TO BE LOCATED BY USING FLURO HOWEVER, IT COULD NOT BE LOCATED. THE PATIENT ENDED UP EXPIRING ON (B)(6) 2020. THE CAUSE OF DEATH INCLUDES CONGESTIVE HEART FAILURE, PROSTHETIC VALVE FAILURE, MITRAL VALVE AND RHEUMATIC HEART DISEASE.

  Patient problems: Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243981 ↗