TRACOE twist plus REF 521-08Recalls & reported problems
Tracoe medical GmbH · Spare Inner Cannulas, with 15 mm Connector, 3 units · Class 2
All models of TRACOE twist plus (13)
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 04035324018208), received between Mar 20, 2026 and Mar 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Compatibility Problem” (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
- Compatibility Problem1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Compatibility Problem
THE NURSE TRIED TO CHANGE THE INNER CANULA. HE REMOVED THE DIRTY INNER CANULA AND TRIED TO INSER THE NEW ONE. IT WAS IMPOSSIBLE TO INTRODUCE THE NEW INNER CANULA IN THE TWIST CANULA. HE DECIDED TO USE AGAIN THE DIRTY CANULA. AFTER THAT, HE LOOKED THE INNER CANULA WITH CAUTION AND HE DISCOVERED THAT THE SIZE OF THE INNER CANULA WAS NOT THE GOOD ONE. IT WAS A SIZE 9 INSTEAD OF A SIZE 8. IN THE PACKAGE THEY RECEIVED A CANULA SIZE 8 WITH 2 INNER CANULA: ONE SIZE 8 AND ANOTHER ONE SIZE 9. THE OXYGEN SATURATION OF THE PATIENT DECREASE AT 40%. THEY SHOULD INCREASE FI02 UNTIL THE SATURATION WENT BACK TO 100% DISCOMFORT OF THE PATIENT.
Patient problems: Low Oxygen Saturation
MAUDE report 24647922 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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