CARBOMEDICS STANDARD A5-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08022057012623), received between Feb 22, 2018 and May 27, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2021Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2015, A PATIENT RECEIVED A CARBOMEDICS STANDARD AORTIC PROSTHESIS A5-023 FOR STREPTOCOCCAL ENDOCARDITIS. AT FIVE MONTHS POST PROCEDURE, THERE WAS EVIDENCE OF STABLE MODERATE PERI PROSTHETIC REGURGITATION. THE PATIENT PRESENTED WITH FEVER AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 REQUIRING METARAMINOL INFUSION. THE ECHO/TOE SHOWED A BORDERLINE DILATED LEFT VENTRICLE, HYPERDYNAMIC SYSTOLIC FUNCTION WITH MODERATE TO SEVERE PROSTHETIC AORTIC REGURGITATION. NO OBVIOUS VEGETATION WAS IDENTIFIED. THE BLOOD CULTURES HAVE BEEN NEGATIVE AND THE SEROLOGY FOR LEGIONELLA WAS POSITIVE. THE PATIENT HAS HYPOALBUMINAEMIA. THE CORONARY ANGIOGRAM SHOWS ONLY MINOR DISEASE. THE PATIENT UNDERWENT A RE-DO AORTIC VALVE REPLACEMENT ON (B)(6) 2020. THE DIAGNOSIS WAS OF POSSIBLE CULTURE NEGATIVE ENDOCARDITIS WITH LEGIONELLA. THE INTRAOPERATIVE FINDINGS SHOWED A MODERATELY LARGE PERI PROSTHETIC SPACE AT THE RIGHT CORONARY ANNULUS. THE UNDERLYING TISSUE WAS WELL HEALED. THE REMAINDER OF THE VALVE WAS EXTREMELY WELL INCORPORATED IN THE ANNULUS. THERE WAS NO OBVIOUS VEGETATION OR PURULENT MATERIAL PRESENT. THE EXPLANTED VALVE WAS REPLACED WITH A NEW A5-023. THE PROCEDURE WAS COMPLETED UNEVENTFULL

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis

  MAUDE report 11891776 ↗
• InjuryMay 27, 2021Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2015, A PATIENT RECEIVED A CARBOMEDICS STANDARD AORTIC PROSTHESIS A5-023 FOR STREPTOCOCCAL ENDOCARDITIS. AT FIVE MONTHS POST PROCEDURE, THERE WAS EVIDENCE OF STABLE MODERATE PERI PROSTHETIC REGURGITATION. THE PATIENT PRESENTED WITH FEVER AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 REQUIRING METARAMINOL INFUSION. THE ECHO/TOE SHOWED A BORDERLINE DILATED LEFT VENTRICLE, HYPERDYNAMIC SYSTOLIC FUNCTION WITH MODERATE TO SEVERE PROSTHETIC AORTIC REGURGITATION. NO OBVIOUS VEGETATION WAS IDENTIFIED. THE BLOOD CULTURES HAVE BEEN NEGATIVE AND THE SEROLOGY FOR LEGIONELLA WAS POSITIVE. THE PATIENT HAS HYPOALBUMINAEMIA. THE CORONARY ANGIOGRAM SHOWS ONLY MINOR DISEASE. THE PATIENT UNDERWENT A RE-DO AORTIC VALVE REPLACEMENT ON (B)(6) 2020. THE DIAGNOSIS WAS OF POSSIBLE CULTURE NEGATIVE ENDOCARDITIS WITH LEGIONELLA. THE INTRAOPERATIVE FINDINGS SHOWED A MODERATELY LARGE PERI PROSTHETIC SPACE AT THE RIGHT CORONARY ANNULUS. THE UNDERLYING TISSUE WAS WELL HEALED. THE REMAINDER OF THE VALVE WAS EXTREMELY WELL INCORPORATED IN THE ANNULUS. THERE WAS NO OBVIOUS VEGETATION OR PURULENT MATERIAL PRESENT. THE EXPLANTED VALVE WAS REPLACED WITH A NEW A5-023. THE PROCEDURE WAS COMPLETED UNEVENTFULL

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis

  MAUDE report 11891772 ↗
• InjuryApr 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS STANDARD AORTIC VALVE A5-023 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2020. NO FURTHER INFORMATION ABOUT ANY DEVICE MALFUNCTION OR PATIENT OUTCOME WAS RECEIVED FROM THE SITE REGARDING THIS EVENT. THE MANUFACTURER REQUESTED ADDITIONAL INFORMATION ON THE EVENT AND RECEIVED COPY OF THE OPERATIONAL REPORT RELATED TO THE PROCEDURE PERFORMED ON (B)(6) 2020. THE PATIENT UNDERWENT A REDO MEDIAN STERNOTOMY AND REDO AORTIC VALVE REPLACEMENT WITH A 23MM CARBOMEDICS FOR POSSIBLE CULTURE NEGATIVE ENDOCARDITIS WITH LEGIONELLA. THE OPERATIONAL NOTE RECEIVED REPORTS INFORMATION ON ONLY ONE VALVE 23MM CARBOMEDICS, THAT WAS REPORTEDLY INSERTED IN AN INTRA-ANNULAR POSITION. THE VALVE SEATED WELL AND THE PROCEDURE WAS COMPLETED UNEVENTFULLY. THE PATIENT WAS DISCHARGED WITH A GOOD OUTCOME AFTER SURGERY. NO INFORMATION IS PRESENT REGARDING THE EXPLANTED CARBOMEDICS VALVE MODEL A5-023.

  Patient problems: Insufficient Information

  MAUDE report 11636013 ↗
• InjuryApr 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS STANDARD AORTIC VALVE A5-023 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2020. NO FURTHER INFORMATION ABOUT ANY DEVICE MALFUNCTION OR PATIENT OUTCOME WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11635999 ↗
• InjurySep 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING TEAM. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, ON (B)(6) 2014, A PATIENT RECEIVED A CARBOMEDICS STANDARD AORTIC VALVE A5-023 IN AORTIC POSITION. THE DEVICE WAS REPORTEDLY EXPLANTED ON (B)(6) 2019, AND IT WAS REPLACED WITH A CARBOMEDICS STANDARD AORTIC VALVE A5-025. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. THE MANUFACTURER DID NOT RECEIVE ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY FOR THE PATIENT FROM THE SITE.

  Patient problems: No Information

  MAUDE report 10486117 ↗
• InjurySep 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING TEAM. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, ON (B)(6) 2014, A PATIENT RECEIVED A CARBOMEDICS STANDARD AORTIC VALVE A5-023 IN AORTIC POSITION. THE DEVICE WAS REPORTEDLY EXPLANTED ON (B)(6) 2019, AND IT WAS REPLACED WITH A CARBOMEDICS STANDARD AORTIC VALVE A5-025. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. THE MANUFACTURER DID NOT RECEIVE ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY FOR THE PATIENT FROM THE SITE.

  Patient problems: No Information

  MAUDE report 10486112 ↗
• InjuryAug 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEIVED INFORMATION ABOUT A CARBOMEDICS STANDARD PROSTHETIC AORTIC HEART VALVE THAT WAS IMPLANTED ON (B)(6) 2019. THE DEVICE WAS EXPLANTED AT AROUND 8 MONTHS LATER ON (B)(6) 2020. OTHER EVENT DETAILS INCLUDING REASON OF THE REPLACEMENT ARE STILL BEING GATHERED.

  Patient problems: No Information

  MAUDE report 10383037 ↗
• InjuryAug 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEIVED INFORMATION ABOUT A CARBOMEDICS STANDARD PROSTHETIC AORTIC HEART VALVE THAT WAS IMPLANTED ON (B)(6) 2019. THE DEVICE WAS EXPLANTED AT AROUND 8 MONTHS LATER ON (B)(6)2020. OTHER EVENT DETAILS INCLUDING REASON OF THE REPLACEMENT ARE STILL BEING GATHERED.

  Patient problems: No Information

  MAUDE report 10383036 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 A PATIENT RECEIVED A CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, A5-023. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED THE SAME DAY. THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION ON FEB. 13, 2019 FROM THE OPERATING PHYSICIAN. DURING THE PROCEDURE THE PATIENT WAS IDENTIFIED AS HAVING PARAVALVULAR LEAK ON TOE AFTER COMING OFF BYPASS. THERE WAS NO PROBLEM WITH THE VALVE ITSELF. THERE WAS A VERY SMALL PARAVALVULAR LEAK BUT BASED ON THE PATIENTS YOUNG AGE THE VALVE WAS EXPLANTED AND A ST. JUDE MEDICAL 23ATJ-503, SN (B)(4), WAS IMPLANTED. THERE WERE NO PROBLEMS WITH THE PATIENT OUTCOME AND THE SITE REPORTED NO VALVE MALFUNCTIONS.

  Patient problems: No Information

  MAUDE report 8177164 ↗
• InjuryMay 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A CARBOMEDICS STANDARD AORTIC VALVE A5-023 WAS IMPLANTED ON (B)(6) 2008. THE VALVE WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH ANOTHER CARBOMEDICS STANDARD AORTIC VALVE OF THE SAME SIZE ON (B)(6) 2018..

  Patient problems: No Information

  MAUDE report 7513120 ↗
• InjuryFeb 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CONFIRMATION THAT EVENT WAS ATTRIBUTED TO MIS-SIZING.

  Patient problems: No Information

  MAUDE report 7291139 ↗