TRACOE vario REF 450-08-PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035324017027), received between Jan 27, 2026 and Jan 27, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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.

• MalfunctionJan 27, 2026Use of Device Problem; Unintended Movement

  1) WHAT WENT WRONG WITH THE DEVICE: ON (B)(6) 2025 IT WAS REPORTED WHILE A PATIENT WAS BEING REPOSITIONED FROM A SUPINE TO A LATERAL POSITION FOR A PUNCTURE, THE TRACHEAL CANNULA BECAME TWISTED INSIDE THE SHIELD DESPITE THE LOCK BEING CORRECTLY ADJUSTED (LOCK SYMBOL CLOSED). AS A RESULT, THE TRACHEAL CANNULA WAS NO LONGER POSITIONED CORRECTLY IN THE TRACHEA AND INITIALLY LEAKED. THE PATIENT THEN HAD TO BE REINTUBATED AS AN EMERGENCY MEASURE BECAUSE VENTILATION WAS IMPOSSIBLE. A BRONCHOSCOPY SHOWED THAT THE CANNULA WAS LYING WITH THE OPENING AGAINST THE MUCOUS MEMBRANE OF THE TRACHEA AND WAS THEREFORE MISPLACED. 2) DESCRIPTION OF HEALTH EFFECTS: NO HARM WAS CAUSED TO THE PATIENT. SHORT-TERM UNDERSUPPLY OF BREATHING AIR.

  Patient problems: Airway Obstruction

  MAUDE report 24187582 ↗