CARBOMEDICS SUPRA-ANNULAR (TOP HAT)Recalls & reported problems across all models

We found 5 models of CARBOMEDICS SUPRA-ANNULAR (TOP HAT) by Corcym Srl in the FDA's device registry (GUDID). Together they are named in 99 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2016 and May 13, 2026 — classified as 21 deaths, 74 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (68 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CARBOMEDICS SUPRA-ANNULAR (TOP HAT) problems

CARBOMEDICS SUPRA-ANNULAR (TOP HAT) models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-021

  HEART-VALVE, MECHANICAL
  7 deaths37 reports
• CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-023

  HEART-VALVE, MECHANICAL
  6 deaths25 reports
• CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-025

  HEART-VALVE, MECHANICAL
  2 deaths17 reports
• CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-019

  HEART-VALVE, MECHANICAL
  4 deaths10 reports
• CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-027

  HEART-VALVE, MECHANICAL
  2 deaths10 reports

Recent CARBOMEDICS SUPRA-ANNULAR (TOP HAT) adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Difficult to Open or Close

  THE MANUFACTURER WAS NOTIFIED OF THE INTRAOPERATIVE EXPLANT OF A CARBOMEDICS TOP-HAT VALVE SIZE 25. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. DURING A STANDALONE SURGICAL AORTIC VALVE REPLACEMENT PERFORMED VIA FULL STERNOTOMY ON (B)(6) 2026, A SIZE 25 PROSTHETIC HEART VALVE WAS IMPLANTED IN A PATIENT WITH SEVERE NATIVE AORTIC STENOSIS. THE AORTIC ANNULUS SIZE WAS REPORTED BY ECHOCARDIOGRAPHY AS 22 MM IN THE ANTEROPOSTERIOR DIAMETER, WITH NO ABNORMAL ANNULAR GEOMETRY IDENTIFIED AND COMPLETE ANNULAR DEBRIDEMENT PERFORMED PRIOR TO IMPLANTATION. IMMEDIATELY AFTER COMPLETION OF SUTURING AND UNCLAMPING OF THE AORTA, THE PATIENT DEVELOPED WEAK LEFT VENTRICULAR CONTRACTION AND SIGNIFICANT ARRHYTHMIAS, INCLUDING REPEATED REFRACTORY VENTRICULAR FIBRILLATION DESPITE DEFIBRILLATION. INTRAOPERATIVE TRANSESOPHAGEAL AND TRANSTHORACIC ECHOCARDIOGRAPHY DEMONSTRATED POOR MOTION OF THE PROSTHETIC VALVE LEAFLETS, WITH INABILITY OF THE LEAFLETS TO OPEN NORMALLY, ABSENCE OF EFFECTIVE BLOOD FLOW THROUGH THE VALVE, AND A RAPID DROP IN BLOOD PRESSURE. NO PARAVALVULAR LEAK, CENTRAL REGURGITATION, OR BLEEDING WAS IDENTIFIED AS THE PRIMARY ISSUE. THE DEVICE W

  Patient problems: Atrial Fibrillation; Ventricular Fibrillation

  MAUDE report 25157905 ↗
• 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 ↗
• InjuryMar 4, 2026Inadequacy of Device Shape and/or Size

  THE MANUFACTURER WAS NOTIFIED OF AN EXPLANT INVOLVING A CARBOMEDICS TOP HAT AORTIC VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER FROM PATIENT/DEVICE TRACKING. ON (B)(6) 2024, A CARBOMEDICS TOP HAT AORTIC VALVE, S5-025, WAS IMPLANTED IN A PATIENT. REPORTEDLY, THE PATIENT DEVELOPED ENDOCARDITIS AND AFTER ABOUT 6 MONTHS, THE VALVE WAS EXPLANTED AND REPLACED WITH A SIMILAR BUT SMALLER SIZE VALVE S5-023 ON (B)(6) 2025. AFTER THE REDO PROCEDURE THE PATIENT WAS PUT ON ECMO, AND LATER WEANED OFF. THE PATIENT UNFORTUNATELY PASSED AWAY DUE TO MULTI ORGAN FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 24505579 ↗
• InjuryMar 4, 2026Insufficient Device Problem Information

  MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT IMPLANT FORM, ON (B)(6) 2025, A CARBOMEDICS TOP HAT AORTIC VALVE, S5-023, WAS IMPLANTED/EXPLANTED INTRA-OPERATIVELY DUE TO UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24504218 ↗
• InjuryAug 20, 2025Break; Break

  ON (B)(6) 2025, A CARBOMEDICS TOP HAT VALVE, S5-021 WAS SUCCESSFULLY IMPLANTED. ONCE ALL SUTURES WERE IN PLACE, THEY STARTED ROTATING THE LEAFLETS WITH A RUBBER SHODDED HEMOSTAT AND A DEBAKEY. IT WAS AT THIS TIME THAT THE LEAFLET BROKE. THEY HAD TO REMOVE THE PIECES, FLUSH AND SUCTION THE AREA AS WELL AS REMOVE THE TOP HAT VALVE AND PLACE A SECOND ONE. THIS ADDED AT LEAST AN HOUR TO THE CASE. THE SECOND TOP HAT WAS PLACED SUCCESSFULLY. AS REPORTED PATIENT IS DOING WELL AND WAS COMING OUT OF THE ICU AND TO THE FLOOR WITH STABLE HEMODYNAMIC AND EXTUBATED.

  Patient problems: Insufficient Information

  MAUDE report 22847320 ↗
• InjuryAug 20, 2025Break; Break

  ON (B)(6) 2025, A CARBOMEDICS TOP HAT VALVE, S5-021 WAS SUCCESSFULLY IMPLANTED. ONCE ALL SUTURES WERE IN PLACE, THEY STARTED ROTATING THE LEAFLETS WITH A RUBBER SHODDED HEMOSTAT AND A DEBAKEY. IT WAS AT THIS TIME THAT THE LEAFLET BROKE. THEY HAD TO REMOVE THE PIECES, FLUSH AND SUCTION THE AREA AS WELL AS REMOVE THE TOP HAT VALVE AND PLACE A SECOND ONE. THIS ADDED AT LEAST AN HOUR TO THE CASE. THE SECOND TOP HAT WAS PLACED SUCCESSFULLY. AS REPORTED PATIENT IS DOING WELL AND WAS COMING OUT OF THE ICU AND TO THE FLOOR WITH STABLE HEMODYNAMIC AND EXTUBATED.

  Patient problems: Insufficient Information

  MAUDE report 22847310 ↗
• DeathJun 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH DEVICE TRACKING AUDIT CONDUCTED. BASED ON THE INFORMATION AVAILABLE, ON (B)(6) 2021, A CARBOMEDICS TOP-HAT AORTIC HEART VALVE, S5-025 WAS IMPLANTED IN A PATIENT. AS REPORTED, THE PATIENT DIED (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22197327 ↗
• DeathJun 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH DEVICE TRACKING AUDIT CONDUCTED. BASED ON THE INFORMATION AVAILABLE, ON (B)(6) 2021, A CARBOMEDICS TOP-HAT AORTIC HEART VALVE, S5-025 WAS IMPLANTED IN A PATIENT. AS REPORTED, THE PATIENT DIED ON (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22197307 ↗
• InjuryJun 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEIVED INFORMATION FROM PATIENT/DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-025 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2025. NO FURTHER INFORMATION ABOUT THE EVENT, DEVICE OR PATIENT OUTCOME HAS BEEN RECEIVED FROM THE SITE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22146569 ↗
• InjuryMar 5, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, A CARBOMEDICS TOP HAT VALVE S5-023 WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT. PRE-PROCEDURE ECHO IMAGING MEASURED AORTA AT APPROXIMATELY 20MM WITH A MEAN PG OF 30. AFTER INITIALLY USING SIZERS AND RULING OUT SIZE 19 AND 21MM, SIZE 23MM TOP HAT WAS SELECTED BASED ON SIZING CRITERIA. DEVICE WAS IMPLANTED UTILIZING 12 STAY SUTURES AND COR KNOT SYSTEM. DUE TO PATIENT'S SMALL ANATOMY, THE SURGEON COMMENTED THAT THERE WAS LITTLE ROOM TO WORK AROUND THE VALVE DURING THE IMPLANTATION AND THE COR KNOT DEVICE WAS PRESENTING SOME CHALLENGES. AFTER DEVICE WAS IMPLANTED, AORTA WAS CLOSED, AND PATIENT WAS GRADUALLY BROUGHT OFF BYPASS AND CROSS CLAMP WAS REMOVED. TEE IMAGING AT THIS TIME REVEALED A PVL AT AN AREA ADJACENT TO THE LEFT CORONARY, THE AREA THE SURGEON WAS STATING THAT HAD LITTLE ROOM WHEN SUTURING. IT WAS ALSO DETERMINED THAT THE COR KNOT PROBABLY PERFORATED THE AORTIC WALL AT THAT TIME CONTRIBUTING TO THE PVL. OPTIONS WERE DISCUSSED AND IT WAS DECIDED TO REMOVE TOP HAT AND IMPLANT EITHER A BIOPROSTHETIC AORTIC VALVE OR ANOTHER MECHANICAL VALVE DEPENDING ON THE CONDITION OF THE AORTA POST EXPLANT. REMOVING THE TOP HAT WAS CHALLENGING DUE TO THE SNUG FIT. REPORTEDLY,

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21522066 ↗
• InjuryMar 5, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, A CARBOMEDICS TOP HAT VALVE S5-023 WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT. PRE-PROCEDURE ECHO IMAGING MEASURED AORTA AT APPROXIMATELY 20MM WITH A MEAN PG OF 30. AFTER INITIALLY USING SIZERS AND RULING OUT SIZE 19 AND 21MM, SIZE 23MM TOP HAT WAS SELECTED BASED ON SIZING CRITERIA. DEVICE WAS IMPLANTED UTILIZING 12 STAY SUTURES AND COR KNOT SYSTEM. DUE TO PATIENT'S SMALL ANATOMY, THE SURGEON COMMENTED THAT THERE WAS LITTLE ROOM TO WORK AROUND THE VALVE DURING THE IMPLANTATION AND THE COR KNOT DEVICE WAS PRESENTING SOME CHALLENGES. AFTER DEVICE WAS IMPLANTED, AORTA WAS CLOSED, AND PATIENT WAS GRADUALLY BROUGHT OFF BYPASS AND CROSS CLAMP WAS REMOVED. TEE IMAGING AT THIS TIME REVEALED A PVL AT AN AREA ADJACENT TO THE LEFT CORONARY, THE AREA THE SURGEON WAS STATING THAT HAD LITTLE ROOM WHEN SUTURING. IT WAS ALSO DETERMINED THAT THE COR KNOT PROBABLY PERFORATED THE AORTIC WALL AT THAT TIME CONTRIBUTING TO THE PVL. OPTIONS WERE DISCUSSED AND IT WAS DECIDED TO REMOVE TOP HAT AND IMPLANT EITHER A BIOPROSTHETIC AORTIC VALVE OR ANOTHER MECHANICAL VALVE DEPENDING ON THE CONDITION OF THE AORTA POST EXPLANT. REMOVING THE TOP HAT WAS CHALLENGING DUE TO THE SNUG FIT. REPORTEDLY,

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21522011 ↗
• InjuryJul 19, 2024Leak/Splash; Leak/Splash

  MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, A CARBOMEDICS TOP HAT S5-023 THAT WAS IMPLANTED AND EXPLANTED INTRAOPERATIVELY ON (B)(6) 2024. BASED ON THE FURTHER INFORMATION RECEIVED, THE DEVICE WAS EXPLANTED DUE TO LEAKAGE/REGURGITATION AND WAS REPLACED WITH A MEDTRONIC AVALUS BIOPROSTHETIC VALVE. NO OTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19784715 ↗
• InjuryJul 19, 2024Leak/Splash; Leak/Splash

  MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, A CARBOMEDICS TOP HAT S5-023 THAT WAS IMPLANTED AND EXPLANTED INTRAOPERATIVELY ON (B)(6) 2024. BASED ON THE FURTHER INFORMATION RECEIVED, THE DEVICE WAS EXPLANTED DUE TO LEAKAGE/REGURGITATION AND WAS REPLACED WITH A MEDTRONIC AVALUS BIOPROSTHETIC VALVE. NO OTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19784708 ↗
• 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 ↗

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