SJM™ Masters SeriesHemashield™ 29CAVGJ-514 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734006514), received between May 17, 2022 and Jan 23, 2023 — classified as 1 injury, 1 malfunction.

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

• 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 ↗
• 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 ↗