CARBOMEDICS STANDARD A5-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08022057012630), received between Dec 24, 2019 and Dec 4, 2025 — classified as 7 injuries, 2 malfunctions.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Break; Break

  THE MANUFACTURER WAS NOTIFIED OF THE INTRAOPERATIVE EXPLANT OF A CARBOMEDICS STANDARD AORTIC VALVE, SIZE 25. THE PROCEDURE WAS AN ISOLATED AORTIC VALVE REPLACEMENT THROUGH FULL STERNOTOMY WITH NO CONCOMITANT PROCEDURES. REPORTEDLY, DURING THE IMPLANTATION OF THE VALVE, ONE OF THE LEAFLETS FRACTURED WHILE THE DEVICE WAS BEING POSITIONED WITHIN THE ANNULUS. BASED ON THE INFORMATION RECEIVED, NO ANOMALOUS MANIPULATION OF THE DEVICE HAS BEEN PERFORMED. THE VALVE WAS THEREFORE EXPLANTED AND ANOTHER CARBOMEDICS STANDARD AORTIC VALVE IN SIZE 25 WAS SUCCESSFULLY IMPLANTED. THE EVENT ADDED 20 MIN IN CROSS-CLAMP TIME AND 20 MIN IN BYPASS TIME. BASED ON THE INFORMATION RECEIVED, THE PATIENT REMAINED STABLE DURING THE DELAY IN SURGERY. THE EVENT WAS INITIALLY DESCRIBED AS A ¿BROKEN CAP¿. HOWEVER, AFTER THE VALVE WAS RECEIVED ON (B)(6) 2025, AND EXAMINED, IT WAS NOTED THAT THE DEVICE HAD A BROKEN LEAFLET AND A BLOOD-STAINED CUFF AND THE EVENT WAS REASSESSED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713651 ↗
• InjuryJun 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS STANDARD AORTIC HEART VALVE A5-025 WAS IMPLANTED ON (B)(6) 2020. IT WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH CARBOMEDICS REDUCED AORTIC HEART VALVE R5-023. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12008796 ↗
• InjuryJun 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS STANDARD AORTIC HEART VALVE A5-025 WAS IMPLANTED ON (B)(6) 2020. IT WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH CARBOMEDICS REDUCED AORTIC HEART VALVE R5-023. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11996798 ↗
• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 A PATIENT RECEIVED A CARBOMEDICS STANDARD A5-025 AS PART OF AN AVR. THE MANUFACTURER IDENTIFIED THAT THE PATIENT HAD A SECOND PATIENT CARD IDENTIFYING ANOTHER CARBOMEDICS STANDARD A5-025 WAS PREVIOUSLY IMPLANTED ON (B)(6) 2019. IT HAS NOT BEEN CONFIRMED BUT THE MANUFACTURER IS CONSERVATIVELY IDENTIFYING THIS EVENT AS AN EXPLANT OF THE CARBOMEDICS STANDARD A5-025 WHICH WAS IMPLANTED ON (B)(6) 2019 AND REPLACED BY A SECOND CARBOMEDICS A5-025 ON (B)(6) 2020.

  Patient problems: No Information

  MAUDE report 10588534 ↗
• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 A PATIENT RECEIVED A CARBOMEDICS STANDARD A5-025 AS PART OF AN AVR. THE MANUFACTURER IDENTIFIED THAT THE PATIENT HAD A SECOND PATIENT CARD IDENTIFYING ANOTHER CARBOMEDICS STANDARD A5-025 WAS PREVIOUSLY IMPLANTED ON (B)(6) 2019. IT HAS NOT BEEN CONFIRMED BUT THE MANUFACTURER IS CONSERVATIVELY IDENTIFYING THIS EVENT AS AN EXPLANT OF THE CARBOMEDICS STANDARD A5-025 WHICH WAS IMPLANTED ON (B)(6) 2019 AND REPLACED BY A SECOND CARBOMEDICS A5-025 ON (B)(6) 2020.

  Patient problems: No Information

  MAUDE report 10588514 ↗
• InjuryAug 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2020, A CARBOMEDICS STANDARD AORTIC VALVE A5-025 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. A SIMILAR VALVE BUT DIFFERENT SIZE A5-023 WAS FINALLY IMPLANTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 10435105 ↗
• InjuryAug 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2020, A CARBOMEDICS STANDARD AORTIC VALVE A5-025 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. A SIMILAR VALVE BUT DIFFERENT SIZE A5-023 WAS FINALLY IMPLANTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 10435038 ↗
• MalfunctionDec 24, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2019, A CARBOMEDICS STANDARD AORTIC WAS INTENDED TO BE IMPLANTED IN A PATIENT. UPON INSPECTION OF THE DEVICE AFTER THE OPENING OF THE BOX, IT WAS IDENTIFIED THAT THE SIZE ON THE LABEL TAG OF THE DEVICE (I.E. 23) DID NOT MATCH WITH THE SIZE ON THE BOX (I.E. A5-025). SINCE THE SERIAL NUMBER OF THE TAG MATCHED THE ONE ON THE VALVE BOX, THE SURGEON DECIDED TO IMPLANT THE DEVICE IN THE PATIENT ASSUMING THAT IT IS A SIZE 25. DESPITE THE LABELING DISCREPANCY, NO OTHER PERCEIVED ISSUES WITH THE DEVICE ARE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THIS VALVE. THE PATIENT WAS NOT ADVERSELY IMPACTED BY THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517053 ↗
• MalfunctionDec 24, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2019, A CARBOMEDICS STANDARD AORTIC WAS INTENDED TO BE IMPLANTED IN A PATIENT. UPON INSPECTION OF THE DEVICE AFTER THE OPENING OF THE BOX, IT WAS IDENTIFIED THAT THE SIZE ON THE LABEL TAG OF THE DEVICE (I.E. 23) DID NOT MATCH WITH THE SIZE ON THE BOX (I.E. A5-025). SINCE THE SERIAL NUMBER OF THE TAG MATCHED THE ONE ON THE VALVE BOX, THE SURGEON DECIDED TO IMPLANT THE DEVICE IN THE PATIENT ASSUMING THAT IT IS A SIZE 25. DESPITE THE LABELING DISCREPANCY, NO OTHER PERCEIVED ISSUES WITH THE DEVICE ARE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THIS VALVE. THE PATIENT WAS NOT ADVERSELY IMPACTED BY THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517036 ↗