TRACOE mini REF 355-3.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035324011971), received between Sep 18, 2024 and Sep 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

1 other recall cover devices cleared under the same FDA submission (K893866); they may or may not involve this specific model.

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.

• MalfunctionSep 18, 2024Loss 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

  TRACOE MINI TRACHEOSTOMY CANNULA BROKE BETWEEN TUBE AND NECK PLATE WHILE THE PATIENT WAS NAPPING. THE TUBE REMAIN IN THE TRACHEA AND BECAME A FOREIGN BODY. THE TRACHEOSTOMY CANNULA WAS IN USE ONLY FOR ONE WEEK. TUBE OF THE CANNULA WAS REMOVED IN HOSPITAL.

  Patient problems: Cough

  MAUDE report 20244227 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K893866. One submission often covers many models, so check the product and lot details in each record.

• Z-1667-2013 · Apr 17, 2013 · Terminated
  Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.