TRACOE® twist REF 301-08-PRecalls & reported problems
Tracoe medical GmbH · Tracheostomy Tube with Low Pressure Cuff, with atraumatic 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 04035324015160), received between Sep 4, 2025 and Sep 4, 2025 — classified as 1 malfunction.
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
Patient problems
- Respiratory Insufficiency1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
1) THE INCIDENT OCCURRED ON (B)(6) 2025 AT APP. 06:30, THE PATIENT DEVELOPED SIGNS OF RESPIRATORY DISTRESS. MULTIPLE SUCTION ATTEMPTS WERE PERFORMED USING BOTH ORAL AND CLOSED SUCTION VIA THE TRACHEOSTOMY TUBE, BUT THESE DID NOT RELIEVE THE OBSTRUCTION. THE INNER CANNULA WAS CHECKED AND APPEARED CLEAR. WHEN ANOTHER DEEP CLOSED SUCTION ATTEMPT WAS MADE, IT BECAME APPARENT THAT THERE WAS A POSSIBLE BLOCKAGE LOCATED DEEPER THAN THE INNER CANNULA. FIO2 WAS INCREASED TO 100% AND THE VENTILATOR WAS DISCONNECTED TO ALLOW THE USE OF A TENDERTIP OPEN SUCTION CATHETER. THIS INTERVENTION PROVIDED PARTIAL RELIEF AFTER SEVERAL PASSES (APPROXIMATELY FIVE ATTEMPTS). DUE TO THE ONGOING DIFFICULTY AND SUSPICION OF A DEEPER BLOCKAGE, THE CLINICAL TEAM PERFORMED A BRONCHOSCOPY. THIS REVEALED WHAT APPEARED TO BE PLASTIC MATERIAL. OBSTRUCTING THE AIRWAY, LEAVING ONLY A SMALL RESIDUAL LUMEN. THE DEVICE'S CUFF HAD SLIPPED DOWN THE SHAFT. OF THE TUBE, PARTIALLY BLOCKING THE PATIENT'S AIRWAY. ALTHOUGH THE CUFF REMAINED ATTACHED, ITS DISPLACEMENT BEYOND THE DISTAL END OF THE TUBE CAUSED THE OBSTRUCTION. THE DECISION WAS MADE TO IMMEDIATELY REPLACE THE TRACHEOSTOMY TUBE. 2)FOLLOWING TUBE EXCHANGE, SUCTIONING
Patient problems: Respiratory Insufficiency
MAUDE report 22960636 ↗
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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