TRACOE mini REF 350-4.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035324011957), received between Aug 18, 2025 and Aug 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 18, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  1) WHAT WENT WRONG WITH THE DEVICE: ACCORDING TO THE COMPLAINT DESCRIPTION AND 1 PICTURE THE TUBE/DISTAL SEGMENT OF THE TRACHEOSTOMY MINI CANNULA DETACHED DURING USE FROM THE NECK FLANGE AND ENDED UP IN THE TRACHEA OF THE PATIENT. THE CANNULA WAS IN USE FOR ABOUT 40 DAYS WITH AN ALLOWED USE TIME OF 29 DAYS AND WAS MEANWHILE DISINFECTED WITH CHLORHEXIDINE. THIS DISINFECTANT MIGHT HAVE AN EFFECT ON THE BONDING OF NECK PLATE TO THE TUBE, WHICH CANNOT BE CONFIRMED. 2) DESCRIPTION OF HEALTH EFFECTS: TUBE NEEDS TO BE REMOVED FROM THE AIRWAY (BRONCHOSCOPIC). NO FURTHER HARM OF THE PATIENT REPORTED.

  Patient problems: Aspiration/Inhalation; Insufficient Information

  MAUDE report 22826744 ↗

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.