TRACOE vario REF 470-08Recalls & reported problems
Tracoe medical GmbH · TRACOE vario extra Tracheostomy Tube with Adjustable Neck Flange, Low Pressure Cuff and Subglottic Suction Line · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04035324013029), received between Jul 29, 2025 and Oct 30, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 reports).
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
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2025Material Separation; Material Separation
1) WHAT WENT WRONG WITH THE DEVICE: AN OBTURATOR IS INSTALLED IN THE LUMEN OF THE TRACHEOSTOMY CANNULA, WHICH MAKES IT EASIER TO INSERT THE CANNULA IN THE TRACHE AND TO REDUCE THE CALIPER GAP BETWEEN THE OUTER DIAMETER OF THE CANNULA AND A GUIDE. IT WAS REPORTED THAT DURING PULLING OUT THE MANDRIN, THE TIP OF THE OBTURATOR BROKE OFF AND REMAINED STUCK IN THE CANNULA. THANKS TO THE QUICK ACTION OF THE STAFF, HARM TO THE PATIENT WAS AVERTED. 2) DESCRIPTION OF HEALTH EFFECTS: NO HEALTH EFFECT OF THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23423351 ↗MalfunctionJul 29, 2025Material Separation; Material Separation
1) WHAT WENT WRONG WITH THE DEVICE: AN OBTURATOR IS INSTALLED IN THE LUMEN OF THE TRACHEOSTOMY CANNULA, WHICH MAKES IT EASIER TO INSERT THE CANNULA IN THE TRACHE AND TO REDUCE THE CALIPER GAP BETWEEN THE OUTER DIAMETER OF THE CANNULA AND A GUIDE. THE OBTURATOR IS PULLED OUT AFTER THE CANNULA HAS BEEN INSERTED INTO THE TRACHEA. WHEN PULLING IT OUT, THE TIP OF THE OBTURATOR BROKE OFF AND GOT STUCK IN THE LUMEN OF THE CANNULA. THIS SEPARATION WAS DISCOVERED IMMEDIATELY AFTER INSERTION AND AFTER IT WAS DETECTED THAT VENTILATION OF THE PATIENT DETERIORATED. AN OTHER CANNULA WAS RE-INSERTED WITHOUT ANY PROBLEM AND VENTILATION CONTINUED. 2) DESCRIPTION OF HEALTH EFFECTS: NO HARM OR DESATURATION OF THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22642467 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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