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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734005821), received between Jan 27, 2022 and May 22, 2023 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT (B)(6) 2023, A 17MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR PROCEDURE. THE VALVE HAD BEEN SIZED USING A 905 MECHINICAL HEART VALVE SIZER SET. IT WAS NOTED DURING PROCEDURE THAT THE LEAFLET OF THE VALVE FRACTURED INTO TWO PIECES WHEN ROTATING THE VALVE. IT WAS NOTED THAT THE VALVE WAS UNABLE TO BE ROTATED WHEN THE LEAFLET FRACTURED. ALL THE PIECES WERE SUCCESSFULLY RECOVERED/REMOVED FROM THE PATIENT. NO OTHER INSTRUMENTS ENCOUNTERED THE VALVE AT THE TIME OF FRACTURE. THE HOLDER HANDLE HAD BEEN FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. THE VALVE WAS IN A CLOSED POSITION WHEN ATTEMPTING TO ROTATE IT AND THE LEAFLET FRACTURED. THE DECISION WAS MADE TO REPLACE THE 17MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WITH A 19MM SJM MASTERS SERIES VALVE EXPANDED CUFF TO COMPLETE THE PROCEDURE. THE PATIENT WAS NOT TAKEN OFF BYPASS AND PLACED BACK ON BYPASS DUE TO THIS EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981415 ↗
• MalfunctionOct 18, 2022Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 17MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR IMPLANT IN AN INTRA-ANNULAR AORTIC PLACEMENT VIA AORTOTOMY. ONCE IMPLANTED THE VALVE WAS IMPLANTED, THE PHYSICIAN TOOK A PLASTIC TIP TO CHECK LEAFLET MOBILITY. IT WAS SHOWN USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THAT THE LEAFLETS WERE NOT PROPERLY COAPTING DUE TO AN OBSTRUCTION OF THE LEAFLETS. THE VALVE WAS NOT ROTATED. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER 17MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE. ANOTHER TEE WAS PERFORMED, AND THE REPLACEMENT VALVE WAS SHOWN TO BE FUNCTIONING NORMALLY. THE AORTOTOMY WAS CLOSED AN THE PROCEDURE CONCLUDED WITHOUT FURTHER INCIDENT. SIGNIFICANT PAST MEDICAL HISTORY INCLUDES A SMALL, HEAVILY CALCIFIED AORTIC ROOT AND TUBULAR AORTA. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620964 ↗
• InjuryJan 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 17MM MASTERS MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE, AS THE VALVE WAS BEING ROTATED, ONE OF THE LEAFLETS CAME OUT FROM THE HINGE MECHANISM. THE VALVE WAS EXCHANGED FOR A NEW NON-ABBOTT VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366623 ↗