Portex 101/870/085Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
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 15019517078015), received between Apr 22, 2026 and Apr 22, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fitting 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fitting Problem1
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.
MalfunctionApr 22, 2026Fitting Problem
IT WAS REPORTED THAT THE INNER CANNULA DID NOT PROPERLY ATTACH TO CANNULA, CAUSING IT TO BECOME LOOSE. WHEN THE ENDO CANNULA IS INSERTED, IT FAILS TO CLICK INTO PLACE AND REMAINS LOOSE. THE BLUE CONNECTOR LINKING THE OXYGEN SUPPLY TO THE ENDOTRACHEAL TUBE KEPT DETACHING WHENEVER AN ATTEMPT WAS MADE TO VENTILATE. THE STATUS OF THE PRODUCT AT TIME OF EVENT WAS DURING USE IN PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM WAS REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957756 ↗
Other Tube, tracheostomy (w/wo connector) devices
- Portex 101/860/080CZIcu Medical, Inc. · Tube, tracheostomy (w/wo connector)188 reports
- Portex 101/860/075CZIcu Medical, Inc. · Tube, tracheostomy (w/wo connector)115 reports
- Bivona 60SP040Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)1 recall20 reports
- Bivona 60SP050Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)1 recall13 reports
- Bivona 60P040Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)1 recall12 reports
- Portex 101/860/070CZIcu Medical, Inc. · Tube, tracheostomy (w/wo connector)60 reports
- Bivona 60SP045Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)1 recall8 reports
- Bivona 60SN040Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)1 recall5 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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