SJM™ Masters SeriesHemashield™ 25CAVGJ-514 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734006316), received between Jan 24, 2022 and Mar 13, 2026 — classified as 6 injuries, 2 malfunctions.

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 8 most recent of 8 reports, 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 ↗
• 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 ↗
• 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 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 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, A 25MM MASTERS SERIES AORTIC VALVE WAS IMPLANTED. POST PROCEDURE, THE PATIENT EXPERIENCED A DROP IN HEMOGLOBIN. TWO UNITS OF RED BLOOD CELLS (RBC) WERE GIVEN ON (B)(6) 2022, AND TWO UNITS OF RBC WERE GIVEN ON (B)(6)2022. THE SOURCE OF THE BLEEDING WAS NOT PROVIDED. ON (B)(6) 2022, THE PATIENT HAD AN ACUTE KIDNEY INJURY WITH INCREASING CREATININE WHILE IN THE INTENSIVE CARE UNIT (ICU). DIURETICS WERE GIVEN AS TREATMENT. THE PATIENT ALSO HAD NEW ST-ELEVATION IN LEAD II AND ATRIAL FIBRILLATION NOTED ON ECG. ON (B)(6) 2022, A LONG-TERM ELECTROCARDIOGRAM (ECG) NOTED EXTRA SYSTOLES AND INTERMITTENT AV BLOCK II. ON (B)(6) 2022, A PACEMAKER WAS IMPLANTED TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia; Heart Block; Hemorrhage/Blood Loss/Bleeding; Renal Failure

  MAUDE report 14073915 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 25MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS IMPLANTED. ON (B)(6) 2021, SUBSTANTIAL POST-OPERATIVE DRAINAGE WAS NOTED. AN ECHOCARDIOGRAM WAS PERFORMED MULTIPLE TIMES PERICARDIAL FLUID LEVELS AND THERE WAS NO NEED FOR RE-EXPLORATION OR PERICARDIOCENTESIS. THE PATIENT WAS ADMINISTRATED COLCHICUM AND IBUPROFEN. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. IT IS THOUGHT THAT POSTPERICARDIOTOMY SYNDROME WAS THE CAUSE OF THE PERICARDIAL EFFUSION. THE PATIENT WAS REPORTED TO IN STABLE CONDITION AND SINCE HAS BEEN DISCHARGED. (B)(4).

  Patient problems: Pericardial Effusion

  MAUDE report 13337890 ↗