SJM™ Masters Series HP 25AHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734006293), received between Aug 27, 2019 and May 2, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMay 2, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR IMPLANTATION. AFTER THE DEVICE WAS IMPLANTED, IT WAS NOTED THAT NEITHER OF THE LEAFLETS WOULD OPEN. IT WAS ALSO NOTED THE VALVE WOULD NOT ROTATE. THE DEVICE WAS REMOVED FROM PATIENT ANATOMY AND REPLACED WITH A NON-ABBOTT DEVICE. THE PATIENT IS REPORTED TO BE FINE AND RECOVERING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854270 ↗
• InjuryOct 26, 2022Fracture; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Fracture; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR PROCEDURE. DURING THE PROCEDURE, THE VALVE WAS ATTEMPTED TO INSERT IN THE AORTIC POSITION THROUGH A WOVEN DACRON'S TUBE. IT WAS ATTEMPTED TO PUSH ON THE VALVE WITH THE SUPPORT HANDLE BUT THIS WAS UNSUCCESSFUL DUE TO FRICTION AND THE SUPPORT HANDLE WAS REMOVED. IT WAS THEN ATTEMPTED TO USE DISSECTION FORCEPS TO PUSH ON THE CUFF TO POSITION THE DEVICE IN THE PATIENT'S ANNULUS BUT THIS WAS UNSUCCESSFUL. A LEAFLET WAS FRACTURED AND THE OTHER LEAFLET DISLODGED AND TRAVELED TO THE PATIENT'S LEFT VENTRICLE. THE DISLODGED LEAFLET AND FRACTURED LEAFLET WERE BOTH REMOVED FROM THE PATIENT AS ONE SINGLE PIECE THE A 25MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS NOT IN THE FULLY CLOSED POSITION WHEN BEING ROTATED, BUT NO RESISTANCE WAS NOTED WHEN ROTATING THE VALVE. THE HOLDER HANDLE HAD BEEN FULLY INSERTED INTO THE VALVE'S ORIFICE AT A 90 DEGREE ANGLE. THE DECISION WAS MADE TO REMOVE THE 25MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE AND REPLACE IT WITH A 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE TO COMPLETE THE PROCEDURE. THE REPLACEMENT VALVE WAS IMPLANTED SUCCESSFULLY. THE PATIENT

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 15676132 ↗
• InjuryAug 27, 2019Material Separation; Material Separation

  ON AN (B)(6) 2019, A 25MM MASTERS VALVE WAS SELECTED FOR IMPLANT. WHILE ATTEMPTING TO ROTATE THE VALVE USING THE HOLDER HANDLE, A LEAFLET WAS DISLODGED FROM THE DEVICE. THE DEVICE WAS EXCHANGED FOR A SECOND 25MM MASTER'S VALVE (SERIAL NUMBER: (B)(4)). THERE WAS A CLINICALLY SIGNIFICANT DELAY TO THE PROCEDURE DUE TO THIS EVENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936675 ↗