SJM™ Masters Series HP 17MHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734030496), received between Jul 4, 2018 and Jul 29, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2020Biocompatibility; Biocompatibility

  RELATED REFERENCE MANUFACTURING REPORT NUMBER: 3007113487-2020-00018. ON (B)(6) 2017, A 15MM MASTERS MITRAL VALVE WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS ADMITTED FOR PLANNED MITRAL VALVE REPAIR DUE TO WORSENING MITRAL VALVE STENOSIS AND PULMONARY HYPERTENSION. ON (B)(6) 2020, THE MITRAL VALVE WAS EXPLANTED AND A NEW 17MM MASTERS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2020, THE PATIENT DEVELOPED FIRST DEGREE HEART BLOCK, COMPLETE HEART BLOCK, AND JUNCTIONAL RHYTHM. THEREFORE, ON (B)(6) 2020, AN EPICARDIAL PACEMAKER WAS IMPLANTED. THE PATIENT IS REPORTED TO BE RECOVERING. CLINICAL STUDY PATIENT ID: (B)(6).

  Patient problems: Complete Heart Block

  MAUDE report 10339057 ↗
• MalfunctionJun 17, 2020Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  ON (B)(6) 2020, A 17MM MASTERS MECHANICAL VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY REPOSITIONING THE DEVICE AFTER IT WAS POSITIONED, CAUSING DISLODGEMENT OF ONE OF THE LEAFLETS. A REPLACEMENT 15MM MASTERS MECHANICAL VALVE WAS IMPLANTED. THE PATIENT DID NOT SUFFER ANY ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10162642 ↗
• InjuryJul 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, A 17MM MASTER SERIES VALVE WAS IMPLANTED IN AN INFANT PATIENT. ON (B)(6) 2018, THE VALVE WAS EXPLANTED AND REPLACED WITH A SECOND 17MM MECHANICAL HEART VALVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Information

  MAUDE report 7662747 ↗