TRACOE vario REF 450-07-PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035324017003), received between Dec 18, 2025 and Dec 18, 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. 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.

• MalfunctionDec 18, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  1) WHAT WENT WRONG WITH THE DEVICE: DURING THE INSERTION OF THE CANNULA (VARIO -P TUBE), THE SILICONE SLEEVE, WHICH WAS SUPPOSED TO BE REMOVED AFTER THE CANNULA WAS INSERTED, WAS NOT REMOVED. WHEN THE DOCTOR NOTICED THIS, HE REMOVED THE CANNULA ALONG WITH THE SILICONE PART, AND INSERTED A NEW CANNULA OF THE SAME TYPE INTO THE PATIENT. IN PARALLEL WITH THIS OPERATION, MANUAL VENTILATION WAS PERFORMED SINCE AN ALERT WAS RECEIVED THAT THE PATIENT WAS NOT CONNECTED TO THE MECHANICAL VENTILATOR, BUT AFTER REPLACING THE CANNULA, AS DESCRIBED ABOVE, THE VENTILATOR WORKED PROPERLY, AND THE PATIENT WAS VENTILATED. 2) DESCRIPTION OF HEALTH EFFECTS: NO HARM WAS CAUSED TO THE PATIENT. IT SHOULD BE NOTED THAT THIS IS THE SECOND SIMILAR EVENT WHICH OCCURED IN THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836610 ↗