TRACOE twist REF 301-07Recalls & reported problems
Tracoe medical GmbH · Tracheostomy Tube with Low Pressure Cuff · 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 04035324032914), received between Aug 18, 2025 and Mar 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Lack of Effect1
- Material Split, Cut or Torn1
- Product Quality Problem1
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.
MalfunctionMar 23, 2026Material Split, Cut or Torn
SUBGLOTTIC PORT FOUND TO HAVE A SPLIT ON THE END WHERE YOU ATTACH THE SYRINGE TO ASPIRATE. UNABLE TO ASPIRATE SECRETIONS. REQUIRED TRACHEOSTOMY CHANGE IN ORDER TO ASPIRATE SUBGLOTTIC PORT NO COMPROMISE TO AIRWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660001 ↗MalfunctionAug 18, 2025Product Quality Problem; Detachment of Device or Device Component; Lack of Effect; Product Quality Problem; Detachment of Device or Device Component; Lack of Effect
1) WHAT WENT WRONG WITH THE DEVICE: THE NECK FLANGE OF THE TRACHEOSTOMY TUBE BECAME DETACHED, RISKING LOSS OF AIRWAY AND RESULTING IN AN UNPLANNED TUBE CHANGE. 2) HEALTH EFFECTS: NO HEALTH EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22825780 ↗
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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