Masters Series™ 19MHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067043719), received between Jun 9, 2025 and Jun 9, 2025 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Fracture; Patient-Device Incompatibility; Fracture; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON 15 DEC. 2014, A 19MM MASTERS MITRAL VALVE WAS SELECTED FOR IMPLANT. ON (B)(6) 2025, IT WAS NOTED THAT THERE WAS A GENERAL NARROWING OF THE VALVE AS THE PATIENT GREW, SO IT WAS DECIDED TO REPLACE THE VALVE. DURING THE REMOVAL OF THE MECHANICAL VALVE, ONE OF THE LEAFLETS BECAME DAMAGED AND FRAGMENTS FELL INTO THE LEFT VENTRICLE. MOST OF THE FRAGMENTS WERE RETRIEVED, BUT A FEW SAND-SIZED PIECES COULD NOT BE FOUND. THE LEFT VENTRICLE WAS WASHED WITH 2 LITERS OF SALINE. AFTER THAT, THE LEFT VENTRICLE WAS CHECKED AGAIN TO CONFIRM THAT THERE WERE NO FRAGMENTS. AN X-RAY WAS TAKEN, BUT NO FRAGMENTS WERE FOUND. THE DEVICE WAS REPLACED WITH AN 25MM MASTERS VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171176 ↗