TRACOE twist REF 301-08Recalls & 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 04035324033010), received between Aug 28, 2024 and Jan 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (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
- Gas/Air Leak2
Patient problems
- Insufficient Information1
- Low Oxygen Saturation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2025Gas/Air Leak; Gas/Air Leak
AFTER A NUMBER OF NOT SPECIFIED DAYS OF USE THE CUFF OR THE CUFF SYSTEM OF THE TRACOE TWIST TRACHEOSTOMY CANNULA LEAKED. DESCRIPTION OF THE INCIDENT: DEFECTIVE CANNULA BALLOON THAT ADHERED TO THE WALL OF RESPIRATORY TRACT. DESCRIPTION OF HEALTH EFFECTS: NO INFORMATION ABOUT ANY HEALTH EFFECT PROVIDED YET.
Patient problems: Insufficient Information
MAUDE report 21135333 ↗MalfunctionAug 28, 2024Gas/Air Leak; Gas/Air Leak
AFTER 14 DAYS (1. CANNULA) AND 21 DAYS (2. CANNULA) OF USE THE CUFF OR THE CUFF SYSTEM OF THE TRACOE TWIST TRACHEOSTOMY CANNULA LEAKED. ON BOTH CANNULAS A TINY LITTLE HOLE WAS DETECTED AT MORE OR LESS THE SAME PLACE. T WAS REPORTED THAT THE PATIENT WAS SHORTLY DESATURATED AND NEED A TUBE CHANGE.
Patient problems: Low Oxygen Saturation
MAUDE report 20083880 ↗
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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