SJM™ Masters Series HP AFHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734055246), received between Oct 5, 2020 and Oct 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

• InjuryOct 5, 2020Obstruction of Flow; Obstruction of Flow

  REFERENCE MANUFACTURER REPORT NUMBER: 2648612-2020-00101. ON (B)(6) 2016, A 27MM MECHANICAL MITRAL VALVE AND A 21MM MECHANICAL AORTIC VALVE WAS IMPLANTED TO REPLACE AN UNKNOWN TISSUE VALVE THAT WAS IMPLANTED IN 2011. THE PATIENT HAS A HISTORY OF ENDOCARDITIS, SYSTEMIC SEPTIC EMBOLI, CARDIOMYOPATHY, HYPERTENSION, SMOKING, PULMONARY HYPERTENSION, BICUSPID AORTIC VALVE AND MODERATE ENLARGEMENT OF ASCENDING AORTA. ON (B)(6) 2020, IT WAS REPORTED THAT THE PATIENT MAY HAVE ENDOCARDITIS AND THAT THERE IS A PLANNED INTERVENTION TO REPLACE THE AORTIC VALVE DUE TO STENOSIS. THERE IS A POSSIBILITY THAT THE MITRAL VALVE WILL BE REPLACED AS WELL.

  Patient problems: Aortic Valve Stenosis; Endocarditis

  MAUDE report 10631745 ↗