SJM™ Masters Series HP 23AHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734006125), received between Jun 11, 2019 and Dec 30, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryDec 30, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2019, A 23MM MASTER MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. HOWEVER, WHEN THEY PUT IN THE VALVE, THE LEAFLETS WOULD NOT MOVE WHEN TESTED. NO TISSUE WAS REPORTED TO BE OBSTRUCTING THE VALVE. IN ADDITION, IT WAS REPORTED THAT THE VALVE WAS CRACKED AND IT IS SUSPECTED THAT THE CRACK HAPPENED UPON EXPLANT. THE SITE SENT AN INDIVIDUAL TO A HOSPITAL DOWN THE STREET TO OBTAIN A NEW VALVE. THE PATIENT REMAINED ON THE TABLE AND ON BYPASS WHILE THE INDIVIDUAL RETRIEVED THE NEW VALVE. THERE WAS A PROLONGED PROCEDURE TIME BY 25-30 MINUTES. A NEW 23MM MASTERS MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9531333 ↗
• InjuryAug 1, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2019, A 23MM MASTERS SERIES VALVE WAS SELECTED FOR IMPLANT. AFTER BEING PLACED, THE PHYSICIAN DETERMINED THE VALVE WAS TOO LARGE AND EXCHANGED IT FOR A 21MM MASTERS SERIES VALVE (SERIAL NUMBER: (B)(4)). NO PATIENT CONSEQUENCES WERE REPORTED, BUT THERE WAS A CLINICALLY SIGNIFICANT DELAY TO SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8850224 ↗
• InjuryJun 11, 2019Positioning Problem; Positioning Problem

  INFORMATION RECEIVED FROM PATIENT DEVICE TRACKING NOTES THAT ON (B)(6) 2019, A 23MM MASTERS VALVE WAS MIS-SIZED TOO LARGE AND WAS EXCHANGED FOR A 21MM MASTERS VALVE (SERIAL NUMBER: (B)(4)). THE SURGEON BELIEVED THAT THE VALVE WAS LARGER THAN THE SIZER MEASURED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8686644 ↗