CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08022057012890), received between Jun 8, 2017 and Apr 5, 2024 — classified as 4 deaths, 6 injuries.

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.

• InjuryApr 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE INFORMATION RECEIVED FROM PATIENT TRACKING DEPARTMENT, A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-019 THAT WAS IMPLANTED ON (B)(6) 2019, WAS EVENTUALLY EXPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19055697 ↗
• InjuryApr 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE INFORMATION RECEIVED FROM PATIENT TRACKING DEPARTMENT, A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-019 THAT WAS IMPLANTED ON (B)(6) 2019, WAS EVENTUALLY EXPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19055687 ↗
• InjuryMar 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING. THE TOP HAT SUPRANUCLEAR VALVE SIZE 19, WHICH WAS IMPLANTED ON (B)(6) 2013, WAS EXPLANTED ON (B)(6) 2020 DUE TO SEVERE AORTIC STENOSIS AND VALVULAR DISEASE. THE ST. JUDE 21MM VALVE WAS IMPLANTED IN THE PATIENT INSTEAD. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 13772158 ↗
• DeathDec 2, 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 S5-019 WAS IMPLANTED ON (B)(6) 2021. THE FORM ALSO INDICATED THAT THE PATIENT PASSED AWAY ON THE SAME DAY. AS REPORTED, THE PATIENT RECEIVED MULTIPLE VALVE REPLACEMENTS. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12917745 ↗
• DeathDec 2, 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 S5-019 WAS IMPLANTED ON (B)(6) 2021. THE FORM ALSO INDICATED THAT THE PATIENT PASSED AWAY ON THE SAME DAY. AS REPORTED, THE PATIENT RECEIVED MULTIPLE VALVE REPLACEMENTS. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12917733 ↗
• InjuryJun 18, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A CARBOMEDICS TOP HAT VALVE MODEL S5-019 WAS INTENDED FOR AN AORTIC VALVE REPLACEMENT (NATIVE VALVE) PROCEDURE. AS CONFIRMED, THE DEVICE WAS TESTED WITH THE DEDICATED TESTER AND NO FAULT WAS IDENTIFIED AT THAT TIME. DURING UNCLAMPING, IT WAS IDENTIFIED THAT THE VALVE WAS STUCK WHEN OPENING, SPECIFICALLY, ONE LEAFLET DID NOT OPEN AND DID NOT ALLOW FLOW. AS SUCH, THE SURGEON REMOVED THE DEVICE AND TRIED TO REPOSITION IT IN THE PATIENT, FIRST TESTING THE VALVE WITH THE DEDICATED TESTERS. THEN, THE VALVE WAS REMOVED, AND A NEW CARBOMEDICS STANDARD AORTIC VALVE WAS PUT IN, WHICH WORKED AT THE TIME OF PLACEMENT. AS REPORTED, THE FUNCTIONALITY OF THE TOP HAT VALVE MODEL S5-019 VALVE WAS APPROVED, THE FAILURE WAS DETECTED WHEN UNPINNING AND AT THIS TIME IT WAS REALIZED THAT THE VALVE LEAFLETS DID NOT OPEN. THERE WAS NO BAD POSITION, IT WAS MEASURED, TESTED AND BROKEN WITH THE DEVICE'S GAUGES AND ROTATORS CORRECTLY.

  Patient problems: Insufficient Information

  MAUDE report 12025763 ↗
• InjuryJun 17, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A CARBOMEDICS TOP HAT VALVE MODEL S5-019 WAS INTENDED FOR AN AORTIC VALVE REPLACEMENT (NATIVE VALVE) PROCEDURE. AS CONFIRMED, THE DEVICE WAS TESTED WITH THE DEDICATED TESTER AND NO FAULT WAS IDENTIFIED AT THAT TIME. DURING UNCLAMPING, IT WAS IDENTIFIED THAT THE VALVE WAS STUCK WHEN OPENING, SPECIFICALLY, ONE LEAFLET DID NOT OPEN AND DID NOT ALLOW FLOW. AS SUCH, THE SURGEON REMOVED THE DEVICE AND TRIED TO REPOSITION IT IN THE PATIENT, FIRST TESTING THE VALVE WITH THE DEDICATED TESTERS. THEN, THE VALVE WAS REMOVED, AND A NEW CARBOMEDICS STANDARD AORTIC VALVE #18 WAS PUT IN, WHICH WORKED AT THE TIME OF PLACEMENT. AS REPORTED, THE FUNCTIONALITY OF THE TOP HAT VALVE MODEL S5-019 VALVE WAS APPROVED, THE FAILURE WAS DETECTED DURING THE WEANING FROM BYPASS AND AT THIS TIME IT WAS REALIZED THAT THE VALVE LEAFLETS DID NOT OPEN. THE VALVE WAS ALREADY SUTURED, AND AT THE TIME OF WEANING FROM BYPASS THERE WAS NO MOVEMENT OF THE LEAFLETS, SO THE PATIENT WAS UNABLE TO EXIT THE EXTRACORPOREAL PUMP. THERE WAS NO BAD POSITION, IT WAS MEASURED, TESTED AND BROKEN WITH THE DEVICE'S GAUGES AND ROTATORS CORRECTLY. THE VALVE WAS REPORTEDLY NOT BROKE OR BROKEN IN THE PROCESS.

  Patient problems: Insufficient Information

  MAUDE report 12021407 ↗
• DeathJul 15, 2019Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  ON (B)(6) 2019, A TOP HAT SIZE 19 WAS REPORTEDLY IMPLANTED/EXPLANTED ON THE SAME DAY. BASED ON THE INFORMATION REPORTED, THE PATIENT PASSED AWAY ON THE SAME DAY. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Death

  MAUDE report 8791469 ↗
• DeathJul 15, 2019Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  ON (B)(6) 2019, A TOP HAT SIZE 19 WAS REPORTEDLY IMPLANTED/EXPLANTED ON THE SAME DAY. BASED ON THE INFORMATION REPORTED, THE PATIENT PASSED AWAY ON THE SAME DAY. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Death

  MAUDE report 8791404 ↗
• InjuryJun 8, 2017Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2017 A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE WAS IMPLANTED. ON (B)(6) 2017 THE DEVICE WAS EXPLANTED AS THE VALVE HAD ONE OF THE LEAFLETS JAMMED. THE SECOND LEAFLET WAS FUNCTIONING BUT WAS DAMAGED DURING EXPLANTATION. A PERCEVAL VALVE WAS CHOSEN BY THE SURGEON TO AVOID HAVING TO RE-SUTURE ON THE SAME AREA AND SINCE EXPLANATION WAS NOT STRAIGHT FORWARD HE OPTED FOR A FASTER SOLUTION LIKE PERCEVAL. THE PATIENT IS DOING WELL.

  Patient problems: No Information

  MAUDE report 6625184 ↗