TRACOE mini REF 356Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035324019069), received between Feb 4, 2025 and Feb 4, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 4, 2025Loss of or Failure to Bond; Appropriate Device Problem Term/Code Not Available; Loss of or Failure to Bond; Appropriate Device Problem Term/Code Not Available

  1) WHAT WENT WRONG: THE 15 MM CONNECTOR OF THE EXTENSION PIECE WAS DISCONNECTED FROM THE EXTENSION TUBE AND WAS STILL ATTACHED TO THE TRACHEOSTOMY TUBE. THEREFOR THE CONNECTION WAS INTERRUPTED AND THE VENTILATOR ALARMED. THE TUBE WAS CHANGED AFTERWARDS, INSTEAD OF REMOVING THE 15 MM CONNECTOR FROM THE TRACHEOSTOMY TUBE. 2) HEALTH EFFECT: SHORT TERM DESATURATION, NO FURTHER HEALTH EFFECT REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21302425 ↗