SJM™ Masters SeriesHemashield™ 21CAVGJ-514 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734006026), received between Jul 30, 2020 and Jan 23, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJul 30, 2020Biocompatibility; Biocompatibility

  IN 2016, A 21MM MASTERS SERIES CAVGJ MECHANICAL VALVE WAS IMPLANTED. ON (B)(6) 2020, THE VALVE WAS EXPLANTED DUE TO THROMBUS THAT WAS UNABLE TO BE REMOVED VIA THROMBOEMBOLISATION. A COMPETITOR'S 23MM SORIN CONDUIT VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Thrombus

  MAUDE report 10343951 ↗