SJM™ Masters Series AJ-501 (REF 21AJ-501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734021104), received between Mar 8, 2019 and Mar 22, 2023 — classified as 1 death, 1 injury.

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

• DeathMar 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE THAT A LEAFLET OF THE VALVE FRACTURED INTO SEVERAL PIECES WHEN PIVOTING THE VALVE. THE PATIENT HAD REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE IMPLANT PROCEDURE. ON (B)(6) 2023, THE PATIENT DIED DUE TO AN UNKNOWN CAUSE.

  Patient problems: Insufficient Information

  MAUDE report 16594837 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS INITIALLY REPORTED THAT THE REPORTED VALVE WAS EXPLANTED AFTER AN IMPLANT PERIOD OF ABOUT 3 MONTHS. BASED ON A FOLLOW-UP CONVERSATION WITH THE PHYSICIAN, IT WAS CONFIRMED THAT THIS 21MM MASTERS VALVE WAS SELECTED FOR IMPLANT, BUT DETERMINED TO BE THE INCORRECT SIZE SO THE DEVICE WAS EXCHANGED TO COMPLETE THE PROCEDURE. THE DEVICE WAS NEVER IMPLANTED IN THE PATIENT.

  Patient problems: Aortic Regurgitation; No Consequences Or Impact To Patient

  MAUDE report 8404483 ↗