TRACOE vario REF 471-09-PRecalls & reported problems
Tracoe medical GmbH · TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff and Subglottic Suction Line, with minimally traumatic insertion system · Class 2
Data updated Oct 16, 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 04035324019342), received between Jul 7, 2026 and Jul 7, 2026 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond1
- Partial Blockage1
Patient problems
- Airway Obstruction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2026Partial Blockage; Loss of or Failure to Bond
IT WAS REPORTED ON (B)(6) 2026 THAT FOLLOWING PROPER DILATION, THE TRACHEAL CANNULA COULD INITIALLY BE PLACED WITHOUT DIFFICULTY. HOWEVER, AFTER THE INTRODUCER WAS REMOVED, A SMALL RUBBER CONE (A TRANSITION ELEMENT TO COMPENSATE FOR THE CHANGE IN CALIBRE BETWEEN THE GUIDE WIRE, INTRODUCER AND CANNULA TIP) REMAINED IN THE LUMEN OF THE TRACHEAL CANNULA. THIS LED TO A NEAR COMPLETE OCCLUSION, MEANING THAT VENTILATION VIA THE NEWLY PLACED TRACHEAL CANNULA WAS NOT POSSIBLE. THE SITUATION WAS RECOGNISED IMMEDIATELY. THE CANNULA WAS REMOVED AND THE AIRWAY WAS SECURED BY ALTERNATIVE MEANS. SUBSEQUENTLY, A SECOND DILATION TRACHEOTOMY SET WAS USED, WITH WHICH THE TRACHEAL CANNULA COULD BE INSERTED WITHOUT COMPLICATIONS. THE PATIENT WAS NOT AT RISK, AS THE RESPONSE WAS PROMPT AND APPROPRIATE.
Patient problems: Airway Obstruction
MAUDE report 25730559 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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