CARBOMEDICS CARBO-SEAL AP-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08022057013460), received between May 23, 2025 and May 23, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem; Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem

  THE MANUFACTURER WAS NOTIFIED OF AN INCIDENT INVOLVING A FAILURE TO IMPLANT AND A LABELLING DISCREPANCY ASSOCIATED WITH A CARBOSEAL ASCENDING AORTIC PROSTHESIS, MODEL AP-021. ACCORDING TO THE REPORT, AFTER COMPLETING THE SIZING PROCEDURE USING THE SIZER ACCESSORIES, THE SURGICAL TEAM ENCOUNTERED DIFFICULTIES IN SEATING THE PROSTHESIS INTO POSITION. DURING THE IMPLANTATION ATTEMPT, THE NURSING STAFF OBSERVED A MISMATCH BETWEEN THE SERIAL NUMBER ON THE ID TAG ATTACHED TO THE PROSTHESIS AND THE SERIAL NUMBERS ON THE OUTER PACKAGING LABELS. THIS DISCREPANCY WAS PROMPTLY BROUGHT TO THE SURGEON¿S ATTENTION. DUE TO CONCERNS REGARDING BOTH THE SEATING DIFFICULTY AND THE SERIAL NUMBER MISMATCH, THE DECISION WAS MADE TO ABANDON THE IMPLANTATION OF THE DEVICE. IT WAS REPORTED THAT THE ISSUE RESULTED IN A SIGNIFICANT EXTENSION OF THE SURGICAL PROCEDURE¿ESTIMATED BETWEEN 40 AND 60 MINUTES¿WITHOUT ADVERSE EFFECTS ON THE PATIENT. BASED ON THE MEDICAL ASSESSMENT, THE DIFFICULTY IN POSITIONING THE PROSTHESIS WAS ATTRIBUTED PRIMARILY TO THE PATIENT¿S COMPLEX ANATOMY. HOWEVER, THE LABELLING INCONSISTENCY RAISED CONCERNS ABOUT THE POTENTIAL USE OF AN INCORRECTLY SIZED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078038 ↗