Portex 101/870/080Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517078008), received between Jan 6, 2026 and Sep 4, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616276 ↗MalfunctionJan 6, 2026Gas/Air Leak
IT WAS REPORTED THAT A CUFF LEAK OCCURRED DURING USE. NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981595 ↗
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
- Portex 101/870/080CZIcu Medical, Inc. · Tube, tracheostomy (w/wo connector)55 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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