CARBOMEDICS STANDARD M7-029Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08022057012739), received between Nov 14, 2019 and Jul 26, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A CARBOMEDICS MECHANICAL STANDARD HEART VALVE M7-029 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2022. BASED ON THE INFORMATION ON PATIENT'S IMPLANT FORM, ON (B)(6) 2022, A SIMILAR DEVICE M7-029 WAS IMPLANTED IN THE PATIENT. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF DEVICE MALFUNCTION NOR OF SERIOUS INJURY ON THE PATIENT FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 15106052 ↗
• InjuryJul 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A CARBOMEDICS MECHANICAL STANDARD HEART VALVE M7-029 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2022. BASED ON THE INFORMATION ON PATIENT'S IMPLANT FORM, ON (B)(6) 2022, A SIMILAR DEVICE M7-029 WAS IMPLANTED IN THE PATIENT. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF DEVICE MALFUNCTION NOR OF SERIOUS INJURY ON THE PATIENT FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 15106046 ↗
• InjuryMay 25, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A CARBOMEDICS STANDARD MITRAL VALVE M7-029 WAS IMPLANTED IN A PATIENT. AFTER IMPLANTATION, VASCULAR ULTRASOUND (TEE) FOUND THAT ONE OF THE LEAFLETS WAS NOT FLEXIBLE MOVED ENOUGH. CONSIDERING THAT THE PATIENT HAD NOT RECEIVED THE ORIGINAL LEAFLET TREATMENT, AND ONE LEAFLET WAS HYPERTROPHY, THE PHYSICIAN REOPENED THE LEAFLET AND ROTATED THE VALVE IN ONE DIRECTION (ABOUT 30 DEGREES COUNTERCLOCKWISE), BUT THE VASCULAR ULTRASOUND OBSERVATION SHOWED THAT THE LEAFLET WAS STILL INFLEXIBLE AND AFFECTED BLOOD FLOW. AS CLARIFIED, DURING TESTING WITH THE DEDICATED LEAFLET TESTER, ONE LEAFLET WAS MOVING NOT VERY SMOOTHLY, AND A RESISTANCE FORCE WAS NOTED DURING THE OPEN AND CLOSE. THE VALVE WAS ULTIMATELY REPLACED WITH A NEW VALVE FROM ANOTHER BRAND (MEDTRONIC #29). AS REPORTED, THE PATIENT HAD INFECTIVE ENDOCARDITIS WITH THICKENED LEAFLET (ANTERIOR EXTERNAL JUNCTION), BUT THE RESECTION OF THE NATIVE MITRAL VALVE DID NOT AFFECT THE FUNCTION OF THE IMPLANTED VALVE. THE PATIENT REMAINED STABLE DURING THE PROCEDURE WHICH WAS COMPLETED UNEVENTFULLY AFTER THE NEW VALVE WAS IMPLANTED. THE PATIENT RECOVERS WELL.

  Patient problems: Insufficient Information

  MAUDE report 11881853 ↗
• InjuryMay 25, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A CARBOMEDICS STANDARD MITRAL VALVE M7-029 WAS IMPLANTED IN A PATIENT. AFTER IMPLANTATION, VASCULAR ULTRASOUND FOUND THAT ONE OF THE LEAFLETS WAS NOT FLEXIBLE MOVED ENOUGH. CONSIDERING THAT THE PATIENT HAD NOT RECEIVED THE ORIGINAL LEAFLET TREATMENT, AND ONE LEAFLET WAS HYPERTROPHY, THE PHYSICIAN REOPENED THE LEAFLET AND ROTATED THE VALVE IN ONE DIRECTION, BUT THE VASCULAR ULTRASOUND OBSERVATION SHOWED THAT THE LEAFLET WAS STILL INFLEXIBLE AND AFFECTED BLOOD FLOW. THE VALVE WAS ULTIMATELY REPLACED WITH A NEW VALVE FROM ANOTHER BRAND (DETAILS UNKNOWN).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881772 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  BASED ON THE ASSESSMENT RECEIVED FROM THE HOSPITAL STAFF, THERE WAS NO EVIDENCE IDENTIFIED TO ATTRIBUTE THE PATIENT'S INFECTION TO THE LIVANOVA DEVICE, WHICH RELATIONSHIP WITH THE EVENT WAS EXCLUDED. THE REMAINDER OF THE INFORMATION PREVIOUSLY SUBMITTED REMAINS UNCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 9325034 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  BASED ON THE ASSESSMENT RECEIVED FROM THE HOSPITAL STAFF, THERE WAS NO EVIDENCE IDENTIFIED TO ATTRIBUTE THE PATIENT'S INFECTION TO THE LIVANOVA DEVICE, WHICH RELATIONSHIP WITH THE EVENT WAS EXCLUDED. THE REMAINDER OF THE INFORMATION PREVIOUSLY SUBMITTED REMAINS UNCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 9324982 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2019, A PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL M7-029 (FOURTH CARDIAC SURGERY FOR THE PATIENT). IN THE ICU, A SERIOUS INFECTION (NOT FURTHER SPECIFIED) WAS OBSERVED IN THE PATIENT. A POTENTIAL LINK WITH THE METAL VALVE (MECHANICAL) WAS SUSPECTED, ALTHOUGH THIS RELATIONSHIP WAS NOT FURTHER SPECIFIED NOR SUPPORTED BY FURTHER DATA. THE PATIENT IS REPORTEDLY BEING MONITORED. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT IS STILL HOSPITALIZED IN THE ICU IN (B)(6) 2019 (MORE THAN 115 DAYS). THE PATIENT HAS TRACHEAL STENOSIS, AND THE PULMONARY PART IS GENERALLY IMPAIRED.

  Patient problems: Unspecified Infection

  MAUDE report 9324909 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2019, A PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL M7-029. DURING THE SAME PROCEDURE, THE PATIENT RECEIVED ALSO A CARBOMEDICS STANDARD AORTIC A5-021 (B)(4), SUBMITTED SEPARATELY). THIS IS REPORTED AS THE PATIENT'S FOURTH CARDIAC SURGERY. IN THE ICU, A SERIOUS INFECTION (NOT FURTHER SPECIFIED) WAS OBSERVED IN THE PATIENT. A POTENTIAL LINK WITH THE METAL VALVE (MECHANICAL) WAS INITIALLY SUSPECTED, ALTHOUGH THIS RELATIONSHIP WAS NOT FURTHER SPECIFIED NOR SUPPORTED BY FURTHER DATA. THE PATIENT IS REPORTEDLY BEING MONITORED. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT IS STILL HOSPITALIZED IN THE ICU ON (B)(6) 2019 (MORE THAN 115 DAYS). THE PATIENT HAS TRACHEAL STENOSIS, AND THE PULMONARY PART IS GENERALLY IMPAIRED. BASED ON THE ASSESSMENT RECEIVED FROM THE HOSPITAL STAFF, THERE WAS NO EVIDENCE IDENTIFIED TO ATTRIBUTE THE PATIENT'S INFECTION TO THE LIVANOVA DEVICE, WHICH RELATIONSHIP WITH THE EVENT WAS EXCLUDED.

  Patient problems: Unspecified Infection

  MAUDE report 9324829 ↗