TRACOE twist plus REF 521-09-XRecalls & reported problems
Tracoe medical GmbH · Spare Inner Cannulas, with 15 mm Connector, 10 units · Class 2
All models of TRACOE twist plus (13)
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 04035324018253), received between Mar 20, 2026 and Mar 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Stenosis” (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
- Device Stenosis1
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.
MalfunctionMar 20, 2026Device Stenosis
DURING ROUTINE BRONCHOSCOPY IT WAS NOT POSSIBLE TO INSERT THE BRONCHOSCOPE. THE LUMEN OF THE INNER CANNULA SHOWS A LUMEN RESTRICTION OF APPROX. 50%, PRESUMABLY DUE TO A MANUFACTURING DEFECT IN THE INNER CANNULA. THE USE OF THE INNER CANNULA COULD LEAD TO A POTENTIALLY LIFE-THREATENING SITUATION. WE HAVE SECURED BOTH THE INNER CANNULA AND THE PACKAGING UNIT. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24648272 ↗
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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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