TRACOE comfort REF 105-06-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035324014514), received between Sep 3, 2025 and Sep 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionSep 3, 2025Material Separation; Material Separation

  THE FLANGE HAD DETACHED FROM THE OUTER TUBE OF THE TRACOE COMFORT TUBE, ALLOWING THE TUBE TO MIGRATE INTO THE TRACHEA AND LODGE IN THE BRONCHUS. UNDER INTRAVENOUS SEDATION AND LOCAL ANAESTHESIA, A SIZE 7.5 TRACHEOSTOMY TUBE WAS TEMPORARILY INSERTED TO PERMIT PASSAGE OF THE BRONCHOSCOPE, AND THE DISPLACED SEGMENT WAS RETRIEVED USING A GRASPING INSTRUMENT. THE AIRWAY WAS RESTORED WITH A FUNCTIONING TUBE, AND THE PATIENT WAS DISCHARGED THE SAME DAY IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951225 ↗