CARBOMEDICS STANDARD A5-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08022057012609), received between May 18, 2017 and Oct 20, 2022 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Difficult to Open or Close” (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.

• InjuryOct 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2022, DURING THE IMPLANTING PROCEDURE OF A CARBOMEDICS STANDARD AORTIC MECHANICAL HEART VALVE, A5-019, THE DAMAGE OF THE VALVE SEWING RINGS ¿ SLIT WAS NOTED WHICH RESULTED IN FAILURE OF THE SUTURES OF THE VALVE AND WHICH THREATENED THE LIFE OF THE PATIENT. THEREAFTER, A NEW VALVE WAS IMPLANTED IN THE PATIENT. BASED ON THE MEDICAL JUDGEMENT RECEIVED, AT THE BEGINNING OF THE OPERATION, NO UNUSUAL THING WAS NOTICED WITH THE VALVE. THE PROBLEM WAS NOTED DURING THE PROCEDURE, WHEN THE STITCHES WERE PLACED IN THE SEWING RING, SO TEARS ARE CAUSED DURING THE PASSAGE OF THE STITCHES THROUGH THE SEWING RING. THEN, IT WAS DECIDED TO USE ANOTHER VALVE AND PROCEDURE WAS PERFORMED SUCCESSFULLY AND THE PATIENT WAS RELEASED FROM THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 15642901 ↗
• DeathMay 18, 2017Incomplete Coaptation; Difficult to Open or Close; Incomplete Coaptation; Difficult to Open or Close

  ON (B)(6) 2017, THE PHYSICIAN IMPLANTED MECHANICAL CARBOMEDICS 19 AORTIC. ON (B)(6) 2017 THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 6577227 ↗