TRACOE vario REF 470-08-PRecalls & reported problems
Tracoe medical GmbH · TRACOE vario extra Tracheostomy Tube with Adjustable Neck Flange, Low Pressure Cuff and Subglottic Suction Line, with minimally traumatic insertion system · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035324017089), received between Dec 19, 2025 and Dec 19, 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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
1) WHAT WENT WRONG WITH THE DEVICE: AFTER THE TRACHEAL CANNULA WAS PLACED WITHOUT COMPLICATIONS USING THE TRACOE VARIO SET, THE GUIDE CATHETER AND WIRE WERE REMOVED ACCORDING TO STANDARD PROCEDURE. IN THE PROCESS, THE CONICAL "RUBBER STOPPER" APPARENTLY DETACHED FROM THE GUIDE CATHETER AND REMAINED STUCK IN THE TRACHEAL CANNULA, MAKING VENTILATION IMPOSSIBLE. IT WAS THEN NO LONGER POSSIBLE TO THREAD THE WIRE. THE CANNULA HAD TO BE REMOVED AND A NEW TRACOE VARIO CANNULA WAS INSERTED WITHOUT WIRE GUIDANCE, WHICH WAS SUCCESSFUL. THIS RESULTED IN AN EMERGENCY SITUATION. 2) DESCRIPTION OF HEALTH EFFECTS: NO HARM TO THE PATIENT. REPORTED. THE PATIENT SURVIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23848007 ↗
Other Tube Tracheostomy And Tube Cuff devices
- Shiley 8CN85HCovidien LP · Tube tracheostomy and tube cuff1 recall2 deaths354 reports
- Shiley 6CN75HCovidien LP · Tube tracheostomy and tube cuff1 recall3 deaths240 reports
- Shiley 7CN80RCovidien LP · Tube tracheostomy and tube cuff2 recalls148 reports
- Bivona 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 670180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall140 reports
- Bivona 670170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall10 deaths132 reports
- Shiley 6CN75RCovidien LP · Tube tracheostomy and tube cuff1 recall1 death121 reports
- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page