SJM Masters Series HPRecalls & reported problems across all models

We found 9 models of SJM Masters Series HP by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jul 4, 2018 and Oct 26, 2023 — classified as 3 deaths, 13 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SJM Masters Series HP problems

SJM Masters Series HP models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SJM™ Masters Series HP 19AHPJ-505

  HEART-VALVE, MECHANICAL
  3 deaths5 reports
• SJM™ Masters Series HP 17AHPJ-505

  HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series HP 21AHPJ-505

  HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series HP 23AHPJ-505

  HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series HP 25AHPJ-505

  HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series HP 17MHPJ-505

  HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series HP 21MHPJ-505

  HEART-VALVE, MECHANICAL
  2 reports
• SJM™ Masters Series HP AEHPJ-505

  HEART-VALVE, MECHANICAL
  1 report
• SJM™ Masters Series HP AFHPJ-505

  HEART-VALVE, MECHANICAL
  1 report

Recent SJM Masters Series HP adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM EPIC PLUS SUPRA WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, THE DEVICE WAS EXPLANTED DUE TO A PARAVALVULAR LEAK OF 8 MMHG AND AVERAGE GRADIENT OF 35 MMHG. A 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS IMPLANTED AS A REPLACEMENT. POST IMPLANT, IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE AND DATE OF THE DEATH IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18013991 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 10, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2021, A 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2023, THE PATIENT HAD A HIGH GRADIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16525536 ↗
• DeathDec 14, 2022Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR IMPLANTATION. PRIOR TO THE PROCEDURE THE PATIENT WAS REPORTED TO BE STABLE. WHILE IMPLANTING THE VALVE, IT WAS NOTED THAT THE LEAFLETS DID NOT OPEN AND CLOSE PROPERLY. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE. IT WAS NOTED THAT THERE WAS A PROLONGED PROCEDURE TIME TO PLACE THE NEW VALVE. IT WAS NOTED THAT THE PATIENT HAD REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT WAS PUT ONTO INTROPICAL SUPPORT. IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON AN UNKNOWN DATE DUE TO CHONDROGENIC SHOCK AND HEART FAILURE. DUE TO CHANGING THE VALVE THE PATIENTS PROCEDURE TIME WAS EXTENDED, POSSIBLY CONTRIBUTING TO PATIENT FATALITY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 15978878 ↗
• MalfunctionOct 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2022, A 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS IMPLANTED INTO A PATIENT. AFTER THE VALVE WAS IMPLANTED, THE LEAFLET ON THE VALVE BROKE. THE VALVE WAS REMOVED AND REPLACED WITH 21MM EPIC SUPRA VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694781 ↗
• 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 ↗
• 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 ↗
• DeathSep 23, 2022Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR IMPLANT. IT WAS NOTED THAT DURING PROCEDURE THE LEAFLETS OF THE VALVE WERE NOT COAPTING PROPERLY. THE DECISION WAS MADE TO EXPLANT THE 19MM MASTERS VALVE AND REPLACE IT WITH A 17MM REGENT VALVE. DUE TO AN UNKNOWN REASON THE PATIENT WAS PRONOUNCED DECEASED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 15474111 ↗
• 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 ↗
• MalfunctionMay 7, 2021Fracture; Material Separation; Fracture; Material Separation

  ON (B)(6) 2021, A 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE IT WAS REPORTED THAT THE LEAFLET BROKE WHILE TRYING TO ROTATE THE VALVE. ALL THE PIECES WERE RECOVERED AND A NEW 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SUCCESSFULLY IMPLANTED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE HOWEVER, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789645 ↗
• MalfunctionOct 21, 2020Fracture; Fracture

  ON (B)(6) 2020, A 21MM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR IMPLANT IN THE PATIENT. ONE OF THE LEAFLETS BROKE INTO 3 PIECES AFTER SUTURING THE VALVE IN PLACE. ALL PIECES OF THE BROKEN LEAFLET AND THE VALVE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR A 19MM MASTERS SERIES HEMODYNAMIC PLUS VALVE. THE PHYSICIAN DOES NOT ATTRIBUTE THIS EVENT TO OVERSIZING, THERE WAS NO OTHER SET AND VALVE AVAILABLE AND TIME WAS RUNNING OUT. THE 19MM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SUCCESSFULLY IMPLANTED. THERE WAS A 20-30 MINUTE CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, BUT THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND EXPERIENCED NO SERIOUS INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712439 ↗
• 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 ↗
• 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 ↗

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