SJM™ Masters Series HP 21MHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734054201), received between Sep 13, 2018 and Oct 29, 2022 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionOct 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2022, A 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS IMPLANTED INTO A PATIENT. AFTER THE VALVE WAS IMPLANTED, THE LEAFLET ON THE VALVE BROKE. THE VALVE WAS REMOVED AND REPLACED WITH 21MM EPIC SUPRA VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694781 ↗
• InjurySep 13, 2018Gradient Increase; Obstruction of Flow; Gradient Increase; Obstruction of Flow

  A FORMER PREMATURE INFANT WAS OPERATED ON IN (B)(6) 2018 FOR CONGENITAL MITRAL INSUFFICIENCY. THE PATIENT HAD TWO FAILED ATTEMPTS TO REPAIR THE MITRAL VALVE WHICH WERE UNSUCCESSFUL DUE TO EXTREMELY FRAGILE AND RAPIDLY REORGANIZING ANNULAR TISSUE. ON (B)(6) 2018, A 21 MM MASTERS SERIES MECHANICAL HEART VALVE WAS PLACED IN THE MITRAL POSITION AND THE PATIENT RECOVERED WELL. ON (B)(6) 2018, THE PATIENT WAS READMITTED FOR RESPIRATORY DYSFUNCTION, INITIALLY TREATED AS ASPIRATION PNEUMONIA. UPON REVIEW OF THE ECHOCARDIOGRAM, IT WAS NOTED THAT THE MITRAL PROSTHESIS HAD THROMBOSED AND WAS NOT FUNCTIONING. THE VALVE WAS FIXED IN A SEMI-OPEN POSITION CAUSING EXTREMELY HIGH DIASTOLIC GRADIENTS AND A LARGE REGURGITATION. ON (B)(6) 2018, THE PATIENT'S CONDITION DETERIORATED AND THE PATIENT WAS PLACED ON V-A ECMO AND ATTEMPTS AT THROMBOLYSIS WERE PERFORMED WITHOUT IMPACT ON PRODUCT PERFORMANCE. ON (B)(6) 2018, THE DECISION TO SURGICALLY INTERVENE WAS MADE AND AS THE FACILITY DID NOT HAVE ANOTHER MECHANICAL HEART VALVE AVAILABLE, A 23 MM TRIFECTA GT VALVE WAS IMPLANTED. UPON EXPLANT OF THE THROMBOSED MHV, PANNUS AND THROMBUS WERE NOTED. THIS INTERVENTION WAS CONSIDERED A LIFESAVING PROCEDURE AND

  Patient problems: Corneal Pannus; Mitral Regurgitation; Thrombus

  MAUDE report 7872255 ↗