CARBOMEDICS STANDARD M7-031Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08022057012746), received between Mar 4, 2016 and Jun 17, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT IMPLANT FORM, ON (B)(6) 2022, A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE, M7-031 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY AND M7-029 WAS IMPLANTED INSTEAD. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT REGARDING THIS EVENT HAS BEEN RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 14735801 ↗
• InjuryJul 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE INFORMATION PROVIDED ON (B)(6) 2021 A CARBOMEDICS 31 MM MITRAL VALVE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12216198 ↗
• InjuryJul 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE INFORMATION PROVIDED ON (B)(6) 2021 A CARBOMEDICS 31 MM MITRAL VALVE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12215223 ↗
• InjuryJun 11, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  A PATIENT RECEIVED A CARBOMEDICS STANDARD M7-031 MECHANICAL MITRAL VALVE ON (B)(6) 2005. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED AS A RESULT OF PANNUS OVERGROWTH ON (B)(6) 2019 AND REPLACED WITH AN ABBOTT MHV. THE PATIENTS POST OPERATIVE COURSE WAS REPORTED TO BE GOOD. THE PATIENT HAD RECEIVED FOLLOW-UP AT ANOTHER HOSPITAL, AND WAS REFERRED TO THE GUNMA PREFECTURAL CARDIOVASCULAR CENTER FOR SYMPTOMS OF SHORTNESS OF BREATH. ON ECHO IT WAS IDENTIFIED THAT ONE OF THE LEAFLETS WAS STUCK IN THE CLOSED POSITION. WHEN THE THORACOTOMY WAS DONE AGAIN, THE LEAFLET WAS STILL CLOSED AND THE THROMBUS WAS ATTACHED. IT OPENED WHEN PRESSED. THE ANTICOAGULATION THERAPY MAY NOT HAVE WORKED WELL, BUT THE DETAILS ARE UNKNOWN BECAUSE THE PATIENT HAD BEEN FOLLOWED UP AT ANOTHER HOSPITAL. BIOPSY RESULTS WERE NEGATIVE FOR INFECTIONS.

  Patient problems: Corneal Pannus

  MAUDE report 8689788 ↗
• InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO A CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL M7-031 IMPLANTED ON (B)(6) 2016. IT WAS EXPLANTED AND REPLACED WITH A SIMILAR DEVICE BUT SMALLER SIZE M7-027 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Information

  MAUDE report 8318942 ↗
• MalfunctionSep 28, 2018Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2018, THE PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL VALVE. THE PATIENT WAS NOT RECOVERING WELL FOLLOWING THE PROCEDURE AND THE ECHO SUGGESTED A PARAVALVULAR LEAK. CONSEQUENTLY, THE SURGEON RE-OPENED ON THE (B)(6). UPON INSPECTION, THE SURGEON FOUND THAT THE IMPLANTATION WAS GOOD BUT ONE OF THE VALVE LEAFLETS APPEARED VERY STIFF AND NOT OPENING. THEREFORE, THE CARBOMEDICS VALVE WAS EXPLANTED AND THE VALVE REPLACED WITH ANOTHER COMPANY'S VALVE.

  Patient problems: Mitral Regurgitation

  MAUDE report 7920665 ↗
• InjuryMar 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 A CARBOMEDICS M7-031 MECHANICAL HEART VALVE WAS IMPLANTED. ON (B)(6) 2018 THE VALVE WAS EXPLANTED AND A SECOND CARBOMEDICS M7031 MECHANICAL HEART VALVE WAS IMPLANTED. THE PHYSICIAN EXPLAINED THAT THE DEVICE WAS EXPLANTED FOR ENDOCARDITIS AND ABSCESS. THERE WAS NO VALVE DYSFUNCTION. THE PATIENT HAS RECOVERED WELL.

  Patient problems: Abscess; Endocarditis

  MAUDE report 7307756 ↗
• InjuryJun 1, 2017Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MANUFACTURER WAS NOTIFIED THAT DURING A MITRAL VALVE REPLACEMENT A MECHANICAL VALVE, SZ 31 WAS ATTEMPTED TO BE IMPLANTED WITHOUT SUCCESS. ANOTHER SIZE WAS THEN IMPLANTED SZ 29 SUCCESSFULLY.

  Patient problems: No Information

  MAUDE report 6606440 ↗
• Mar 4, 2016Device Handling Problem; Difficult to Open or Close; Mechanical Jam; Device Handling Problem

  THE COMPANY WAS NOTIFIED ON (B)(6) 2016 ABOUT AN ISSUE RELATED TO A CARBOMEDICS STANDARD MITRAL VALVE (MODEL M7-031, SERIAL # (B)(4)). ON (B)(6) 2016, P.S.((B)(4)) (B)(6) MALE PATIENT, IMPLANTED THE VALVE ABOVE MENTIONED. THIS VALVE WAS IMPLANTED AND IT WAS THEN OBSERVED THAT ONE OF THE LEAFLETS WAS STUCK AND WOULDN'T OPEN. THAT VALVE WAS EXPLANTED AND ANOTHER MITRAL VALVE WAS IMPLANTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 5479438 ↗