Masters Series™ 21MHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067043733), received between Feb 29, 2024 and Feb 29, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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.

• InjuryFeb 29, 2024Perivalvular Leak; Off-Label Use; Perivalvular Leak; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS CHOSEN FOR IMPLANT IN THE TRICUSPID POSITION. DURING PROCEDURE, THE PHYSICIAN USED AN EVERTING MATTRESS TECHNIQUE WITH PLEDGETS ON THE ATRIAL SIDE AND ORIENTED THE VALVE IN AN ANTI-ANATOMICAL POSITION. AFTER SUTURING THE VALVE, THE PHYSICIAN CHECKED FOR LEAFLET MOTION WITH A Q TIP AND WAS SATISFIED. THE BYPASS WAS TURNED OFF, BUT THE ECHOCARDIOGRAM SHOWED A MODERATE PERIVALVULAR LEAK (PVL). THE PHYSICIAN WAS VERY FAMILIAR WITH THE JET'S ASSOCIATED WITH OUR LEAFLET DESIGN, BUT THIS LOOKED DIFFERENT TO HIM, THE PATTERN OF THE JET DESIGN WAS NOT CENTRAL BUT EXTERNAL IN NATURE. A DECISION WAS MADE TO REPLACE THE VALVE AND THE PHYSICIAN TURNED ON THE BYPASS. A NEW 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS CHOSEN AND IMPLANTED USING THE SAME TECHNIQUE BUT THEY ORIENTED THE VALVE 45 DEGREE'S FROM THE ORIGINAL ORIENTATION. THE PHYSICIAN TURNED OFF THE BYPASS AND AN ECHO WAS PERFORMED, NO PERIVALVULAR LEAK (PVL) WAS NOTED. THERE WAS NO REPORTED CONSEQUENCES TO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808985 ↗