CARBOMEDICS STANDARD A5-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08022057012616), received between Nov 14, 2019 and Dec 29, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

• MalfunctionDec 29, 2023Fracture; Fracture

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A CARBOMEDICS STANDARD PROSTHETIC AORTIC HEART VALVE SIZE 21. REPORTEDLY, THE VALVE WAS FRACTURED DURING THE IMPLANT PHASE OF THE SURGERY. ANOTHER AORTIC VALVE OF THE SAME BRAND BUT SMALLER SIZE (A5-019) WAS IMPLANTED INSTEAD, AND THE OPERATION WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18422240 ↗
• MalfunctionSep 29, 2023Fracture; Fracture

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023 A LEAFLET BREAKAGE WAS EXPERIENCED WHILE IMPLANTING A SIZE 21 CARBOMEDICS STANDARD AORTIC MECHANICAL VALVE. REPORTEDLY, THE PATIENT WAS NOT AFFECTED IN CONSEQUENCE OF THE EVENT. THE MANUFACTURER IS FOLLOWING UP WITH THE SITE TO RETRIEVE ADDITIONAL INFORMATION ON THE EVENT AND THE DEVICE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842170 ↗
• InjuryMar 16, 2023Fracture; Fracture

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT. AS REPORTED, ON 13 FEB 2023, CARBOMEDICS STANDARD AORTIC HEART VALVE SIZE 21, A5-021 WAS BROKEN DURING THE OPERATION WHILE PLACING IT TO THE RIGHT ANATOMICAL POSITION. REPORTEDLY, THERE WAS NO ISSUE WITH THE LEAFLETS AND THERE WAS NO NEGATIVE OUTCOME ON THE PATIENT. REPORTEDLY, THERE WAS NO EFFECT ON THE PATIENT AND PATIENT WAS STABLE THROUGH THE DELAY IN THE SURGERY. BASED ON THE INFORMATION RECEIVED, NO DEVICE FAILURE HAS BEEN RECORDED PRIOR TO THIS EVENT, LEAFLETS AND WERE OKAY. REPORTEDLY, IT HAS COME OFF THE HINGE. IN ORDER TO PREVENT LEAKAGE INTO THE VENTRICLE, ONE OF THE LEAFLETS WAS BROKEN WHILE IT WAS BEING REMOVED BY GRASPING THE LEAFLETS. THE MAIN PROBLEM WAS IN THE HINGE SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16559736 ↗
• 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 AORTIC A5-021. DURING THE SAME PROCEDURE, THE PATIENT RECEIVED ALSO A CARBOMEDICS STANDARD MITRAL M7-029 (SUBMITTED IN REPORT ID 3005687633-2019-00259). 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.

  Patient problems: Unspecified Infection

  MAUDE report 9325171 ↗
• 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 AORTIC A5-021. DURING THE SAME PROCEDURE, THE PATIENT RECEIVED ALSO A CARBOMEDICS STANDARD MITRAL M7-029 LN REF # (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 IN DEC 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 9325074 ↗