TRACOE twist REF 501-08-XRecalls & reported problems
Tracoe medical GmbH · Spare Inner Cannulas, with 15 mm Connector, 10 units · Class 2
Data updated Oct 18, 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 04035324017904), received between Feb 20, 2026 and Feb 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Difficult to Insert
ON (B)(6) 2026 IT WAS REPORTED THAT WHEN ATTEMPTING TO CHANGE TRACHEOSTOMY INNER CANNULA IN ONE OF THE ITU PATIENTS, IT WAS NOTED THAT THE TUBE WAS UNABLE TO BE FULLY INSERTED. CHECKED WITH ANOTHER INNER CANNULA FROM THE SAME BATCH NUMBER (1100048974) AND SAME ISSUE IDENTIFIED. TRIED WITH A NEW TRACHEOSTOMY TUBE AND SIMILAR HAPPENED - WAS ABLE TO INSERTED AND REMOVED BUT WITH SIGNIFICANT RESISTANCE AND IMPOSING A REAL RISK DISPLACEMENT OF PATIENT ARTIFICIAL AIRWAY IF USED. NO HEALTH EFFECT ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24398361 ↗
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- Bivona 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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