CARBOMEDICS STANDARD M7-033Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08022057012753), received between Apr 19, 2018 and Jul 16, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL VALVE. UPON BYPASS WEANING, A MITRAL VALVE PROSTHESIS DYSFUNCTION WAS NOTED AS ALSO CONFIRMED ON ARRIVAL AT ICU WITH TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PATIENT PRESENTED ACUTE PROSTHESIS DYSFUNCTION, WITH A FIXED DISC, FOR WHICH A MITRAL VALVE REPLACEMENT WAS AGAIN PERFORMED, CURRENTLY COMPLICATED WITH PNEUMONIC PROCESS, ACUTE KIDNEY INJURY AND RESOLUTION OF SEPTIC SHOCK OVER TIME WITH MECHANICAL VENTILATION. THE DEVICE WAS REPLACED WITH A BIOLOGICAL VALVE PERIMOUNT MITRAL 31.

  Patient problems: Pneumonia; Septic Shock; Unspecified Kidney or Urinary Problem

  MAUDE report 12181512 ↗
• InjuryJul 15, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL VALVE. UPON BYPASS WEANING, A MITRAL VALVE PROSTHESIS DYSFUNCTION WAS NOTED AS ALSO CONFIRMED ON ARRIVAL AT ICU WITH TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PATIENT PRESENTED ACUTE PROSTHESIS DYSFUNCTION, WITH A FIXED DISC, FOR WHICH A MITRAL VALVE REPLACEMENT WAS AGAIN PERFORMED, CURRENTLY COMPLICATED WITH PNEUMONIC PROCESS, ACUTE KIDNEY INJURY AND RESOLUTION OF SEPTIC SHOCK OVER TIME WITH MECHANICAL VENTILATION. THE DEVICE WAS REPLACED WITH A BIOLOGICAL VALVE PERIMOUNT MITRAL 31.

  Patient problems: Pneumonia; Septic Shock; Unspecified Kidney or Urinary Problem

  MAUDE report 12178564 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A CARBOMEDICS STANDARD M7-033 WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2018, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM. IT WAS REPORTED THAT THERE WAS A POSSIBLE DEVICE DYSFUNCTION; HOWEVER, NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7972157 ↗
• InjuryMay 1, 2018Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2018 A CARBOMEDICS STANDARD M7-033 MECHANICAL MITRAL VALVE WAS IMPLANTED. DURING THE OPERATION A FLUID TEST WAS PERFORMED AND CENTRAL LEAKAGE/REGURGITATION WAS OBSERVED THROUGH THE VALVE LEAFLETS. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER CARBOMEDICS STANDARD M7-033 MECHANICAL VALVE. THE FAILURE TO IMPLANT RESULTED IN 20 MINUTES OF ADDTIONAL X-CLAMP TIME. THE PATIENT HAD A NORMAL RECOVERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7478478 ↗
• InjuryApr 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2013 THE PATIENT RECEIVED A MITRAL VALVE REPLACEMENT AND A CARBOMEDICS STANDARD M7-033 WAS IMPLANTED. ON (B)(6) 2015 THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER CARBOMEDICS M7-033 STANDARD MITRAL VALVE.

  Patient problems: No Information

  MAUDE report 7444160 ↗