CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08022057012920), received between Aug 25, 2017 and May 13, 2026 — classified as 2 deaths, 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 17 most recent of 17 reports, 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 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 ↗
• 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 ↗
• InjuryMay 3, 2023Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, AN ATTEMPT WAS MADE TO IMPLANT A CARBOMEDICS TOP HAT AORTIC MECHANICAL HEART VALVE, S5-025. AT THE INTRA-OPERATIVE ECHO CHECK IT WAS OBSERVED THAT LEAFLETS WERE NOT CLOSING PROPERLY, LEADING TO CENTRAL REGURGITATION. THE VALVE WAS REPLACED WITH A NEW ONE OF THE SAME MODEL AND SIZE, S5-025. BASED ON FURTHER INFORMATION RECEIVED, CROSS CLAMP AND BYPASS TIME INCREASED SIGNIFICANTLY BECAUSE OF THIS EVENT. APPROXIMATELY 3 HOURS OF CLAMP TIME WERE ADDED AS THE SURGEON DECIDED TO REPLACE THE VALVE AFTER TRYING TO REPAIR THE POSSIBLE LEAKS AND AFTER MULTIPLE CONSULTATIONS. THE PATIENT'S CARDIAC FUNCTION SIGNIFICANTLY DETERIORATED DURING THE PROCEDURE OWING TO PERSISTING REGURGITATION WHICH LED TO MULTIPLE VT EPISODES FOR WHICH SHOCK HAD TO BE DELIVERED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16865281 ↗
• InjuryFeb 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACING. ON (B)(6) 2020, TOP HAT CARBOMEDICS VALVE SIZE 25 WAS EXPLANTED. THIS VALVE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. THE TOP HAT CARBOMEDICS VALVE SIZE 27 WAS IMPLANTED AS A REPLACEMENT. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY FOR THE PATIENT WAS RECEIVED FROM THE HOSPITAL REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13546421 ↗
• InjuryDec 23, 2021Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-025 WAS IMPLANTED ON (B)(6) 2014. AFTER MORE THAN 7 YEARS, THE DEVICE WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH ANOTHER CARBOMEDICS TOP HAT MECHANICAL HEART VALVE (B)(6). NO ALLEGATION OF A DEVICE MALFUNCTION OR SERIOUS PATIENT INJURY WAS RECEIVED FROM THE HOSPITAL REGARDING THIS EVENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE PATIENT WAS BEING TREATED FOR ENDOCARDITIS. THE PATIENT HAS A HISTORY OF RECENT ENDOCARDITIS IN (B)(6) 2021. THE PATIENT WAS TREATED AT THAT TIME WITH IV ANTIBIOTICS AND THEN HAD NEGATIVE CULTURE TWICE. THE WEEKS PRIOR TO THE ADMISSION TO THE HOSPITAL ON (B)(6) 2021, THE PATIENT STARTED HAVING FEVERS AGAIN AND WAS POSITIVE FOR STREPTOCOCCUS. THE PATIENT WAS TREATED WITH ROCEPHIN IV. THE PATIENT WAS DIAGNOSED WITH COVID IN (B)(6) 2019 (PATIENT FULLY VACCINATED IN (B)(6) 2021). ON ADMISSION, THE PATIENT WAS DIAGNOSED WITH INTERMITTENT THIRD-DEGREE AV BLOCK, REQUIRING CARDIAC CATHETERIZATION AND TEMPORARY PACEMAKER IMPLANT. BASED ON THE FINDINGS REPORTED ON

  Patient problems: Abscess; Endocarditis; Fever; Insufficient Information

  MAUDE report 13082169 ↗
• InjuryDec 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-025 WAS IMPLANTED ON (B)(6) 2014. AFTER MORE THAN 7 YEARS, THE DEVICE WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH ANOTHER CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-023. NO FURTHER INFORMATION ABOUT ANY DEVICE MALFUNCTION OR PATIENT OUTCOME WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13082138 ↗
• InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  HOLD FOR CR 10/16 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 S5-025 WAS IMPLANTED ON (B)(6) 2021. THIS VALVE WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH A CARBOMEDICS TOP HAT VALVE S5-027. THE MANUFACTURER WAS ALSO INFORMED THAT THE PATIENT PASSED AWAY ON THE SAME DAY AFTER THE IMPLANT OF S5-027 (SUBMITTED SEPARATELY UNDER (B)(6)). 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 11895130 ↗
• InjuryMay 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 S5-025 WAS IMPLANTED ON (B)(6) 2021. THIS VALVE WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH A CARBOMEDICS TOP HAT VALVE S5-027. THE MANUFACTURER WAS ALSO INFORMED THAT THE PATIENT PASSED AWAY ON THE SAME DAY AFTER THE IMPLANT OF S5-027 (SUBMITTED SEPARATELY UNDER 3005687633-2021-00132). 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 11895095 ↗
• MalfunctionMar 25, 2021Difficult to Open or Close; Difficult to Open or Close

  ON 09 OCT 2020, A CARBOMEDICS TOP HAT S5-025 WAS INTENDED FOR AN AORTIC VALVE REPLACEMENT PROCEDURE. AFTER THE BOX OF THE VALVE WAS OPENED, THE VALVE WAS CHECKED AND NO DEFICIENCIES WERE IDENTIFIED, SO THE VALVE WAS IMPLANTED. AFTER FINISHING THE SUTURE OF THE VALVE, THE VALVE WAS TESTED WITH THE DEDICATED ACCESSORIES PROVIDED, BUT THE LEAFLET ROTATION WAS FOUND NOT SO SMOOTH. SINCE A MALFUNCTION IN THE DEVICE WAS SUSPECTED, THE VALVE WAS IMMEDIATELY EXPLANTED AND REPLACED A NEW VALVE WITH THE SAME MODEL S5-025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE NEW S5-025. NO IMPACT FOR THE PATIENT WAS REPORTED, WHO RECOVERED AND BEEN DISCHARGED FROM HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572595 ↗
• InjuryJan 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 REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT VALVE S5-025 WAS IMPLANTED ON (B)(6) 2015. THE VALVE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A NEW TOP HAT S5-025. 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: No Information

  MAUDE report 11128356 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-027 IMPLANTED ON (B)(6) 2015 IN AORTIC POSITION. IT WAS EXPLANTED AND REPLACED WITH A SIMILAR DEVICE BUT SMALLER SIZE S5-025 ON (B)(6) 2015. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8332958 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-025 IMPLANTED ON (B)(6) 2014 IN AORTIC POSITION. IT WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE CARBOMEDICS STANDARD MECHANICAL HEART VALVE A5-023 ON (B)(6) 2015. NO FURTHER EVENT DETAILS WERE PROVIDED AND VALVE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8329463 ↗
• InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-025 IMPLANTED ON (B)(6) 2016 IN AORTIC POSITON. IT WAS EXPLANTED AND REPLACED WITH A MITROFLOW VALVE DLA25 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Information

  MAUDE report 8318998 ↗
• InjuryAug 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 28TH JULY 2017 THE MANUFACTURER RECEIVED NOTIFICATION THROUGH PATIENT TRACKING OF A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-025 THAT WAS IMPLANTED ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2017. A NEW CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-023 WAS THEN IMPLANTED. ON FOLLOW UP WITH THE PHYSICIAN ,THE MANUFACTURER WAS INFORMED THAT ONE MONTH POST-OPERATIVE THE PATIENT PRESENTED WITH CHEST PAIN, SMALL TROPONIN RISE (NSTEMI), ECHO SHOWED A SLIGHT DECREASE IN MOTION OF ONE OF THE LEAFLETS. THE PATIENT'S INR WAS NORMAL. THE PATIENT WAS TREATED WITH ANTICOAGULANT AND DISCHARGED HOME. GRADIENTS DECREASED AND CRP WAS NORMAL. ON FOLLOW-UP 2.5 MONTHS POST IMPLANT TEE SHOWED NORMAL FINDINGS. ONE WEEK AFTER THIS FOLLOW UP THE PATIENT RE-PRESENTED AS UNWELL. AT THIS TIME CRP WAS ELEVATED (FOR THE FIRST TIME) AND TEE SHOWED ROOT ABSCESS. THE DEVICE WAS EXPLANTED AND NEW MECHANICAL VALVE S5-023 IMPLANTED. THE PATIENT HAD UNCOMPLICATED RECOVERY AND WAS DISCHARGED. THE EXPLANTED VALVE WAS SENT TO THE HOSPITAL'S MICROBIOLOGY FOR EVALUATION, THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Chest Pain; Endocarditis

  MAUDE report 6821484 ↗