CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-027Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08022057012937), received between Feb 27, 2020 and Mar 5, 2026 — classified as 2 deaths, 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS NOTIFIED OF AN EXPLANT INVOLVING A CARBOMEDICS TOP HAT MECHANICAL AORTIC VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER FROM PATIENT/DEVICE TRACKING AND THE SITE. ON (B)(6) 2022, A CARBOMEDICS TOP HAT AORTIC VALVE, S5-027, WAS IMPLANTED IN A 24 VALSALVA GRAFT IN THE PATIENT. LATER THE PATIENT DEVELOPED OSTEOMYELITIS FROM A TOE WHICH WAS AMPUTATED, MRSA BACTEREMIA, AND TEE AND CT SCAN SHOWED THE PRESENCE OF A ROOT ABSCESS. DUE TO ENDOCARDITIS AND THE ROOT ABSCESS, AFTER ABOUT 3 YEARS FROM IMPLANT, ON (B)(6) 2025 THE VALVE WAS EXPLANTED AND REPLACED WITH A 25MM MAGNA EASE VALVE WHILE THE ROOT WAS REPLACED WITH A 24 CARDIAL ROOT. AFTER THE REOPERATION, TEE SHOWED NORMAL FUNCTIONING BIOPROSTHESIS NO PARAVALVULAR LEAK AND PRESERVED VENTRICULAR FUNCTION. MEAN GRADIENT WAS 19 WITH A VERY HYPERDYNAMIC HEART. THE PATIENT HAS RECOVERED AND WAS DISCHARGED ON (B)(6) 2025. THE SITE DISCARDED THE VALVE AFTER THE PROCEDURE.

  Patient problems: Endocarditis

  MAUDE report 24520797 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS NOTIFIED OF AN EXPLANT INVOLVING A CARBOMEDICS TOP HAT MECHANICAL AORTIC VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER FROM PATIENT/DEVICE TRACKING AND THE SITE. ON (B)(6) 2022, A CARBOMEDICS TOP HAT AORTIC VALVE, S5-027, WAS IMPLANTED IN A 24 VALSALVA GRAFT IN THE PATIENT. LATER THE PATIENT DEVELOPED OSTEOMYELITIS FROM A TOE WHICH WAS AMPUTATED, MRSA BACTEREMIA, AND TEE AND CT SCAN SHOWED THE PRESENCE OF A ROOT ABSCESS. DUE TO ENDOCARDITIS AND THE ROOT ABSCESS, AFTER ABOUT 3 YEARS FROM IMPLANT, ON (B)(6) 2025 THE VALVE WAS EXPLANTED AND REPLACED WITH A 25MM MAGNA EASE VALVE WHILE THE ROOT WAS REPLACED WITH A 24 CARDIAL ROOT. AFTER THE REOPERATION, TEE SHOWED NORMAL FUNCTIONING BIOPROSTHESIS NO PARAVALVULAR LEAK AND PRESERVED VENTRICULAR FUNCTION. MEAN GRADIENT WAS 19 WITH A VERY HYPERDYNAMIC HEART. THE PATIENT HAS RECOVERED AND WAS DISCHARGED ON (B)(6) 2025. THE SITE DISCARDED THE VALVE AFTER THE PROCEDURE.

  Patient problems: Endocarditis

  MAUDE report 24520304 ↗
• MalfunctionMay 16, 2024Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A CARBOMEDICS TOP HAT SIZE 27 MECHANICAL PROSTHESIS. REPORTEDLY, THE IMPLANTING SURGEON NOTICED THAT ONE OF THE VALVE LEAFLETS WAS INTERMITTENTLY GETTING STUCK AND NOT CLOSING COMPLETELY. AS SUCH THE PROSTHESIS WAS REPLACED WITH A NEW TOP HAT MECHANICAL VALVE OF THE SAME SIZE. AS REPORTED, AFTER IMPLANTING THE AORTIC MECHANICAL VALVE, THE ASCENDING AORTA WAS EXCISED AND A 34 MM KNITTED IMPREGNATED PROSTHESIS WAS IMPLANTED FROM THE SINOTUBULAR JUNCTION CLOSE TO THE ARCH OF AORTA. THE PROSTHESIS WAS SEWN USING THREE CONTINUOUS 4-0 PROLEN SUTURES, WHICH WERE THEN TIED TOGETHER. THE SIZE OF THE ASCENDING AORTA WAS 58MM BEFORE THE OPERATION. AS REPORTED, THE TOP HAT VALVE HAD BEEN IMPLANTED USING THREE CONTINUOUS 2-0 PROLENE SUTURES TIED TOGETHER WITH 9 KNOTS ON EACH TO SECURE THE PROSTHESIS AFTER LANDING; IT WAS REPORTED THAT NO PRESSURE HAD BEEN APPLIED ON THE VALVE, THE HOLDER HAD BEEN REMOVED AFTER LANDING AND THE SUTURE POSITION HAD BEEN CHECKED FOR POSSIBLE INTERFERENCE WITH THE LEAFLETS AND A SUFFICIENT GAP (AT LEAST 5MM) BETWEEN THE ENDS OF THE 2-0 PROLEN SUTURE AND THE FREE EDGE OF THE LEAFLETS OF THE PROSTHESIS HAD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333759 ↗
• InjuryAug 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED ON THE PATIENT IMPLANT FORM, ON (B)(6) 2020 A TOP HAT SIZE 27 WAS IMPLANTED INTO THE PATIENT. ON (B)(6) 2021 THE TOP HAT SIZE 27 WAS REMOVED AND A TOP HAT SIZE 25 WAS IMPLANTED. NO ALLEGATION OF A DEVICE MALFUNCTION OR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12287762 ↗
• DeathMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT VALVE S5-027 WAS IMPLANTED (B)(6) 2021 TO REPLACE A CARBOMEDICS TOP HAT VALVE S5-025 (SUBMITTED SEPARATELY UNDER 3005687633-2021-00131). THE PATIENT DIED DURING THE SAME DAY. NO ALLEGATION OF A DEVICE MALFUNCTION OR ADVERSE EVENT HAS BEEN RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11895265 ↗
• DeathMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT VALVE S5-027 WAS IMPLANTED (B)(6) 2021 TO REPLACE A CARBOMEDICS TOP HAT VALVE S5-025 (REF. 2021-02791). THE PATIENT DIED DURING THE SAME DAY. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE ABOUT THE CAUSE OF THE EVENT. NO ALLEGATION OF A DEVICE MALFUNCTION WAS RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 11895224 ↗
• InjuryNov 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT MECHANICAL VALVE S5-027 WAS IMPLANTED ON (B)(6) 2020 AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: No Information

  MAUDE report 10805576 ↗
• InjuryNov 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT MECHANICAL VALVE S5-027 WAS IMPLANTED ON (B)(6) 2020 AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: No Information

  MAUDE report 10805574 ↗
• InjuryFeb 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019 A PATIENT RECEIVED A CARBOMEDICS S5-027 TOP HAT MECHANICAL AORTIC VALVE. THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2019 THE VALVE WAS EXPLANTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9766514 ↗
• InjuryFeb 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019 A PATIENT RECEIVED A CARBOMEDICS S5-027 TOP HAT MECHANICAL AORTIC VALVE. THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2019 THE VALVE WAS EXPLANTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9766490 ↗