SJM™ Masters SeriesHemashield™ 23CAVGJ-514 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734006149), received between Jul 4, 2018 and Sep 23, 2022 — classified as 4 injuries.

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

• 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 ↗
• InjuryApr 6, 2022Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED ON (B)(6) 2022, A 23MM SJM MASTERS SERIES COATED AORTIC VALVE WAS SELECTED FOR IMPLANT. AFTER PLACING THE VALVE, A LEAK TEST WAS PERFORMED, AND IT WAS NOTED THAT THERE WAS A PARAVALVULAR LEAK (PVL) BETWEEN THE CONNECTION OF THE CUFF AND THE ARTIFICIAL VESSEL. A BENTALL PROCEDURE WAS PERFORMED AND A 4-0 SIZE OF PROLENE WITH A PLEDGET WAS USED TO STITCH WHERE THE BLOOD WAS LEAKING. THE LEAK WAS SUCCESSFULLY CLOSED, AND THE DEVICE REMAINS IMPLANTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14019088 ↗
• InjuryMar 29, 2019Fracture; Fracture

  ON (B)(6) 2019, A 23MM MASTERS VALVED GRAFT WITH HEMASHIELD TECHNOLOGY WAS SELECTED FOR IMPLANT IN A 32 YEAR OLD MALE PATIENT DURING A BENTALL PROCEDURE. DURING PROXIMAL ANASTOMOSIS, A SUCTION CATHETER WITH A METAL TIP WAS USED TO SECURE SUTURES AND CAUSED A LEAFLET OF THE VALVE TO FRACTURE. ALL PIECES OF THE FRACTURED LEAFLET WERE REMOVED FROM THE PATIENT AND THE VALVE WAS EXPLANTED. THE PROCEDURE WAS COMPLETED WITH A 25MM MASTERS VALVED GRAFT WITH HEMASHIELD TECHNOLOGY. PER SITE, PROCEDURE AND BYPASS TIMES WERE SIGNIFICANTLY EXTENDED TO REVISE THE CONDUIT AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8463879 ↗
• InjuryJul 4, 2018Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2018, A 23 MM MASTERS SERIES AORTIC VALVED GRAFT WAS CHOSEN FOR IMPLANT. ONCE THE VALVE WAS IMPLANTED AND THE PATIENT WAS REMOVED FROM BYPASS, A BLOOD LEAK WAS OBSERVED. THE VALVE WAS REPLACED WITH ANOTHER 23 MM MASTERS SERIES AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7662764 ↗