SJM™ Masters SeriesHemashield™ 27CAVGJ-514 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734006422), received between Nov 18, 2020 and Feb 13, 2026 — classified as 1 death, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• DeathApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM MASTERS AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS. ON (B)(6) 2022, PATIENT'S C-REACTIVE PROTEIN WAS 237.3 MG/L. ON (B)(6) 2022, THE PATIENT HAD A SEVERE ISCHEMIC STROKE WITH MRS SCORE OF 5. THE PATIENT WAS UNCONSCIOUS WITH NO NOTICEABLE REACTION TO STIMULI AND NO REFLEXES. THE PATIENT HAD LEFT-SIDED PARESIS. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED ACUTE ISCHEMIC CHANGES AND A SWELLING OF ALMOST THE ENTIRE RIGHT HEMISPHERE OF THE BRAIN. THE PATIENT WAS INTUBATED AND PLACED ON MECHANICAL VENTILATION. MEDICATIONS INCLUDING ANTIBIOTICS, ANTIFUNGAL, NARCOTICS, DIURETICS, SEDATIVES, BETA BLOCKERS, AND ANTICOAGULANTS WERE ADMINISTERED. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM THE IMPLANT SITE HOSPITAL AND TRANSFERRED TO ANOTHER HOSPITAL. THE PATIENT'S SYMPTOMS WERE ONGOING AT TIME OF TRANSFER. THERE WERE NO DEVICE DEFICIENCIES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Brain Injury; Respiratory Insufficiency; Stroke/CVA

  MAUDE report 14217124 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 27MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS IMPLANTED. ON (B)(6) 2021, VIA ECHOCARDIOGRAM A PERICARDIAL EFFUSION SPANNING THE ENTIRE HEART WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND 480ML OF BLOODY SECRETION WAS REMOVED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS TRANSFERRED BACK TO THE NORMAL WARD AFTER SPENDING SOME TIME IN THE INTENSIVE CARE UNIT (ICU). IT IS THOUGH THAT THE PERICARDIAL EFFUSION WAS DUE TO A INFLAMMATORY REACTION TO THE SURGERY. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. (CRD_992 - VALVED GRAFTS PAS; EU0123 -303; R643214001).

  Patient problems: Pericardial Effusion

  MAUDE report 12967111 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 27MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE CLINICAL EXPERIENCING DYSPNEA, WEAKNESS, ABDOMINAL DISCOMFORT, ATRIAL FIBRILLATION (AF), DIZZINESS AND ANXIETY. MEDICATION WAS GIVEN TO TREAT THE AF. AN ECHOCARDIOGRAM WAS PERFORMED A PERICARDIAL TAMPONADE WAS NOTED. A PROCEDURE WAS PERFORMED AND LIQUID WAS REMOVED. IT IS THOUGHT THAT POSTOPERATIVE BLEEDING OR POSTPERICARDIOTOMY SYNDROME CAUSED THE TAMPONADE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS DISCHARGED ON (B)(6) 2021. (CRD_992 - VALVED GRAFTS PAS; PL4195-251; R628368101).

  Patient problems: Abdominal Pain; Atrial Fibrillation; Cardiac Tamponade; Dizziness; Dyspnea; Muscle Weakness/Atrophy

  MAUDE report 12625008 ↗
• MalfunctionNov 18, 2020Fracture; Material Separation; Fracture; Material Separation

  ON (B)(6) 2020, A 27MM MASTERS SERIES CAVG WAS SELECTED FOR IMPLANT IN THE PATIENT. DURING DEVICE IMPLANTATION, THE VALVE LEAFLETS SNAPPED. THE PHYSICIAN USED THE VALVE ROTATOR RECOMMENDED IN THE IFU, BUT RESISTANCE WAS FELT AND ONE LEAFLET WAS INTACT AND THE OTHER SHATTERED AS IT FELL INTO THE LEFT VENTRICLE. ALL PIECES OF THE DISLODGED LEAFLET AND FRACTURED PIECES WERE REMOVED FROM THE PATIENT AND THE PATIENT DID NOT EXPERIENCE ANY SERIOUS INJURIES. THE VALVE WAS REPLACED WITH A 25MM MASTERS SERIES CAVG AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. AN INCREASED BYPASS TIME WAS REPORTED. THE PATIENT IS CURRENTLY STABLE AND DISCHARGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10864525 ↗