SJM Masters SeriesHemashieldRecalls & reported problems across all models

We found 5 models of SJM Masters SeriesHemashield by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Jul 4, 2018 and Mar 13, 2026 — classified as 1 death, 16 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 SeriesHemashield problems

SJM Masters SeriesHemashield models

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

• SJM™ Masters SeriesHemashield™ 25CAVGJ-514 00

  HEART-VALVE, MECHANICAL
  8 reports
• SJM™ Masters SeriesHemashield™ 27CAVGJ-514 00

  HEART-VALVE, MECHANICAL
  1 death7 reports
• SJM™ Masters SeriesHemashield™ 21CAVGJ-514 00

  HEART-VALVE, MECHANICAL
  4 reports
• SJM™ Masters SeriesHemashield™ 23CAVGJ-514 00

  HEART-VALVE, MECHANICAL
  4 reports
• SJM™ Masters SeriesHemashield™ 29CAVGJ-514 00

  HEART-VALVE, MECHANICAL
  2 reports

Recent SJM Masters SeriesHemashield adverse event reports

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

• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS CHOSEN FOR A PROCEDURE. AFTER IMPLANTATION, CARDIOPULMONARY BYPASS TIME WAS LONGER THAN USUAL AND SERIOUS A BLEEDING WAS OCCURRED BETWEEN THE GRAFT AND THE VALVE. THE ACTIVATED CLOTTING LEVELS WERE 200. AFTER ANASTOMOSIS, CROSS CLAMP WAS OFF. WHEN THE PATIENT WAS STILL ON CARDIOPULMONARY BYPASS, ACT WAS AROUND 450-550. WHILE DOING BLEEDING CONTROL, A LEAKAGE WAS OCCURRED FROM THE ROOT TO THE DISTAL. FOR BLEEDING CONTROL, PROTAMINE, THROMBOCYTE SUSPENSION (TS), TDP ( FRESH FROZEN PLASMA) WERE GIVEN, THEY HAD TO PUT MORE SUTURES AND BIO GLUE WAS USED. ONE AND TWO UNITS OF BLOOD TRANSFUSION WAS REQUIRED. THE BLEEDING WAS BROUGHT UNDER CONTROL. THE PHYSICIAN MENTIONED THE CAUSE OF BLEEDING MIGHT BE GRAFT PARAZITY. THE SURGEON THOUGHT THAT BLEEDING WAS COMING FROM THE VALVE OR PERSPIRATION ON THE GRAFT WAS TOO MUCH. BECAUSE WHILE ASPIRATING, SEALING OF THE VALVE BECAME WHITE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24589711 ↗
• MalfunctionFeb 13, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 27MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS CHOSEN FOR A PROCEDURE. DURING THE IMPLANTATION, IT WAS FOUND THAT THE VALVE RING WAS DAMAGED, SO IT WAS REPLACED WITH A NON-ABBOTT VALVE FOR THE PROCEDURE WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332305 ↗
• MalfunctionJan 23, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS CHOSEN FOR A PROCEDURE. DURING PREPARATION, THE LEAFLET FUNCTION WAS TESTED USING A PLASTIC HOSE. DURING THE OPERATION, THE DOCTOR TRIED TO TEST THE VALVE LOBE AS NORMAL WHEN THE LEAFLETS STUCK. THE VALVE GOT REMOVED AND A SAME UNKNOWN VALVE WAS IMPLANTED WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160964 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS CHOSEN FOR A PROCEDURE. AFTER THE IMPLANT, THE PHYSICIAN FOUND THAT THE ARTIFICIAL BLOOD VESSEL WAS BLEEDING AND THE SITUATION COULD NOT BE IMPROVED. THE VALVE WAS REMOVED AND REPLACED WITH A NEW 25MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23791063 ↗
• MalfunctionJul 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579183 ↗
• InjuryJun 6, 2025Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM MASTERS SERIES HEART COATED AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE ANNULAR DIMENSIONS OF THE PATIENT'S NATIVE AORTIC VALVE WERE NOT GIVEN. THERE WAS NO DIFFICULTY EXPERIENCED ATTEMPTING TO IMPLANT THE 21MM MASTERS SERIES HEART COATED AORTIC VALVED GRAFT. POST-PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD AORTIC REGURGITATION. THE DECISION WAS MADE EXPLANT THE 21MM MASTERS SERIES HEART COATED AORTIC VALVED GRAFT AND REPLACE IT WAS A 21MM REGENT HEART VALVE WITH FLEX CUFF AND NON-ABBOTT GRAFT DEVICE. THE PATIENT WAS REMOVED OFF CARDIOPULMONARY BYPASS (CPB) AND THEN PUT BACK ON CPB FOR FURTHER INTERVENTION. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE, BUT THE PATIENT WAS MEDICALLY MANAGED. THE PATIENT DID NOT HAVE ANY OTHER CLINICAL SIGNS OR SYMPTOMS AFTER THIS EVENT AND NO INITIAL OR PROLONGED HOSPITALIZATION. THE CAUSE OF THE AORTIC REGURGITATION IS RELATED TO A NOTABLE PERIVALVULAR LEAK OF THE 21MM MASTERS SERIES HEART COATED AORTIC VALVED GRAFT. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22157950 ↗
• InjuryJan 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS SELECTED FOR USE IN A BENTALL PROCEDURE. DURING THE PROCEDURE, THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 100-110 SECONDS. A BLOOD TRANSFUSION WAS REQUIRED. IT WAS NOTED DURING PROCEDURE THAT AFTER THE VALVED GRAFT WAS IMPLANTED, THERE WAS BLOOD LEAKAGE THROUGHOUT THE AREA, INCLUDING THE AREA WHERE THE ARTIFICIAL VALVE AND ARTIFICIAL BLOOD VESSEL OF THE VALVED GRAFT WERE CONNECTED. THE AREA WAS REINFORCED WITH A PERICARDIAL PATCH AND HEMOSTATIC MATERIAL. AFTER THE PROCEDURE, THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.8. THE PHYSICIAN WAS NOT SURE IF THE CAUSE OF THE BLEEDING WAS DUE TO A LEAK FROM THE BLOOD VESSEL OR A GAP BETWEEN THE BLOOD VESSEL AND THE VALVE. THE PATIENT WAS REPORTED AS STABLE AND WAS LATER DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18527622 ↗
• MalfunctionNov 6, 2023Product Quality Problem; Device Markings/Labelling Problem; Product Quality Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM MASTERS VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE PHYSICIAN DISCOVERED THAT THE DIMENSIONS FOR THE OUTER DIAMETER OF THE VALVE WAS NOT 25MM AND IT'S LESS THAN THAT AND FOR THE GRAFT IT WAS 31MM. THE DEVICE WAS IMPLANTED IN THE PATIENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075106 ↗
• InjurySep 19, 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 MASTERS SERIES AORTIC VALVED GRAFT WAS SELECTED FOR IMPLANT IN A PATIENT WITH A DEFORMED AND TORTUOUS AORTA. AFTER IMPLANTING THE VALVE, THE PATIENT WAS BLEEDING CONTINUOUSLY AND BECAME HEMODYNAMICALLY UNSTABLE REQUIRING A BLOOD TRANSFUSION. THE PHYSICIAN ALLEGED THAT THE DEFORMED AORTA WAS THE CAUSE OF THE BLEEDING POST IMPLANT OF THE VALVE. PATIENT STATUS IS UNKNOWN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17775719 ↗
• MalfunctionMay 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS CHOSEN FOR IMPLANT. AFTER THE DEVICE WAS PLACED AND SECURED, IT WAS NOTICED THAT OF THE LEAFLETS WAS NOT IN ITS HOUSING. NO INSTRUMENTS WERE IN CONTACT WITH THE VALVE AT THE TIME OF DISLODGEMENT. THE LEAFLET WAS RETRIEVED FROM THE LEFT VENTRICLE AND THE DEVICE WAS EXPLANTED. AN UNKNOWN SIZE NON-ABBOTT VALVE WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900343 ↗
• MalfunctionMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, IT WAS NOTICED ONE OF THE LEAFLETS HAD BECOME COMPLETELY DETACHED IN ONE PIECE. IT WAS REPORTED THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. THE DETACHED LEAFLET WAS REMOVED FROM THE PATIENT'S BODY. A DECISION WAS MADE TO REPLACE THE DEVICE. THERE WAS NO ATTEMPT MADE TO REINSERT THE DETACHED LEAFLET. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865527 ↗
• MalfunctionJan 23, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, ONE OF THE LEAFLET DID NOT OPEN CORRECTLY. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 29MM MASTERS SERIES MECHANICAL HEART VALVE THAT WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224738 ↗
• InjurySep 23, 2022Incomplete Coaptation; Adverse Event Without Identified Device or Use Problem; Incomplete Coaptation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2002, A 23MM MASTERS VALVE WAS IMPLANTED. PATIENT MAINTAINS INR AROUND 2.0 AND HAS BEEN COMPLIANT. ON (B)(6) 2022, DECREASED LEAFLET MOBILITY WAS OBSERVED AND MEDICAL TREATMENT WAS ADMINISTERED. THE PATIENT IS PLANNED FOR A PROCEDURE TO "EITHER CLEAN OUT VALVE OR REPLACE" BUT THIS HAS NOT BEEN SCHEDULED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Urinary Tract Infection

  MAUDE report 15474028 ↗
• InjurySep 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2022 A 25MM MASTERS SERIES HEART COATED AORTIC VALVED GRAFT WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE HOLDER HANDLES WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. THE PHYSICIAN ROTATED THE VALVE WITH THE VALVE ROTATOR, NO RESISTANCE WAS FELT. THE LEAFLET FELL OFF AND WAS COMPLETELY REMOVED FROM THE PATIENT. DEVICE WAS EXCHANGE WITH A NEW 25MM MASTERS SERIES HEART COATED AORTIC VALVED GRAFT THAT WAS IMPLANTED. THE PATIENT REMAINS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT'S SURGERY TIME WAS EXTENDED BY MORE THAN AN HOUR, AND THE CARDIOPULMONARY BYPASS MACHINE WORKED FOR MORE THAN AN HOUR, HOWEVER NO INJURY WAS REPORTED. THE PATIENT IS CURRENTLY BEGIN OBSERVED IN THE INTENSIVE CARE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470987 ↗
• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY (B)(4) - VALVED GRAFTS PAS, PATIENT ID: (B)(6), SITE: (B)(6). THIS EVENT IS BEING CONSERVATIVELY REPORTED AS THE CAUSE OF THE BLEEDING WAS UNKNOWN DURING AN EMERGENCY SURGICAL SURGERY. IT WAS REPORTED THAT ON (B)(6) 2022, A 29MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED DURING AN EMERGENCY SURGERY PROCEDURE. AFTER DISCONNECTION FROM CARDIOPULMONARY BYPASS, THE PATIENT HAD FLUID BLOOD CONTENT IN THE PERICARDIAL SAC. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 615, AND HEPARIN WAS ADMINISTERED. THE PATIENT RECEIVED TWO UNITS OF FRESH FROZEN PLASMA (FFP) AND TWO UNITS OF RED BLOOD CELL CONCENTRATE. ON (B)(6) 2022, A THORACOTOMY WAS PERFORMED UNDER ANESTHESIA AT THE ENDOTRACHEAL SITE. THERE WAS PERICARDIAL EFFUSION WITHOUT TAMPONADE. THERE WAS FLUID BLOOD CONTENT AND CLOTS IN THE PERICARDIAL SAC. SETONAGE WAS REMOVED. SUTURES APPLIED ON A SMALL SIDING ON THE VENOUS BYPASS TO THE RIGHT CORONARY ARTERY. FOLLOW UP DID NOT REVEAL ANY SURGICAL BLEEDING POINTS. THE PATIENT WAS DISCHARGED ON (B)(6) 2022. AS OF (B)(6) 2022, THE PATIENT IS STABLE. THE CAUSE OF BLEEDING WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 14426994 ↗

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