CARBOMEDICS CARBO-SEAL AP-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08022057013477), received between Jun 8, 2018 and Nov 17, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, A PATIENT WAS INTENDED TO RECEIVE A CARBOSEAL DEVICE MODEL AP-023. THE DEVICE WAS EXPLANTED INTRAOPERATIVELY BECAUSE DURING DECANNULATION, IT WAS NOTICED THE CONDUIT WAS BROKEN; THE VALVE APPEARED SEPARATED FROM THE CONDUIT. THE PATIENT ULTIMATELY RECEIVED A CARBOMEDICS REDUCED 23MM (R5-023) AND A VASCUTEK CONDUIT. THE PATIENT WAS NOT AFFECTED BY THE EVENT. PER ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT NO ALTERATIONS WERE IDENTIFIED IN THE GRAFT AT THE TIME OF IMPLANTATION. ONCE OUT OF THE EXTRACORPOREAL CIRCULATION, IT IS REPORTED THAT A SIGNIFICANT BLEEDING WAS NOTED FROM THE AORTIC ROOT. IT IS CANNULATED THROUGH THE GROIN, BYPASS WAS RESTARTED AND IT WAS IDENTIFIED THAT THE CONDUIT WAS BROKEN. THE VALVE APPEARED SEPARATED FROM THE CONDUIT (ABOUT 2 CM). NO COMPLICATIONS ASSOCIATED WITH THE PROCEDURE WERE REPORTEDLY IDENTIFIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Known Impact Or Consequence To Patient

  MAUDE report 10857131 ↗
• InjuryNov 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, A PATIENT WAS INTENDED TO RECEIVE A CARBOSEAL DEVICE MODEL AP-023. THE DEVICE WAS EXPLANTED INTRAOPERATIVELY BECAUSE DURING DECANNULATION, IT WAS NOTICED THE CONDUIT WAS BROKEN; THE VALVE APPEARED SEPARATED FROM THE CONDUIT. THE PATIENT ULTIMATELY RECEIVED A CARBOMEDICS REDUCED 23MM (R5-023) AND A VASCUTEK CONDUIT. THE PATIENT WAS NOT AFFECTED BY THE EVENT. PER ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT NO ALTERATIONS WERE IDENTIFIED IN THE GRAFT AT THE TIME OF IMPLANTATION. ONCE OUT OF THE EXTRACORPOREAL CIRCULATION, IT IS REPORTED THAT A SIGNIFICANT BLEEDING WAS NOTED FROM THE AORTIC ROOT. IT IS CANNULATED THROUGH THE GROIN, BYPASS WAS RESTARTED AND IT WAS IDENTIFIED THAT THE CONDUIT WAS BROKEN. THE VALVE APPEARED SEPARATED FROM THE CONDUIT (ABOUT 2 CM). NO COMPLICATIONS ASSOCIATED WITH THE PROCEDURE WERE REPORTEDLY IDENTIFIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Known Impact Or Consequence To Patient

  MAUDE report 10857122 ↗
• InjuryJun 8, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ON (B)(6) 2018 A CARBOSEAL AP-023 MECHANICAL AORTIC HEART VALVE PROSTHESIS WAS IMPLANTED. IT WAS REPORTED ONE OF THE LEAFLETS WAS STUCK. THE DEVICE IS BEING RETURNED FOR ANALYSIS THUS INTRA-OPERATIVE EXPLANT IS ASSUMED BUT NO CONFIRMATION HAS BEEN RECEIVED.

  Patient problems: No Information

  MAUDE report 7584513 ↗