Portex 101/810/075CZRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517076295), received between Jan 11, 2024 and Apr 3, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (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
- Gas/Air Leak1
- Inflation Problem1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Gas/Air Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CUFF LEAKED AND THEN THE CUSTOMER FOUND THERE WAS A SECRETION IN THE PILOT BALLOON. WHILE CUFF TESTING PROCESS IS NORMAL AND WAS NOT IN CONTACT WITH ANY SHARP OBJECTS DURING INSERTING. THERE WAS 1 QUANTITY AFFECTED. THE EVENT OCCURRED IN HOSPITAL WHILE IN USE WITH PATIENT. THE ISSUE WAS RESOLVED BY CHANGING TO A NEW PRODUCT. NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781385 ↗MalfunctionAug 19, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT AFTER THE INSTALLATION ON THE PATIENT; IT WAS NOTICED THAT THE SET WAS PUNCTURED AND NEEDED TO BE REPLACED TO AVOID HARM TO THE PATIENT. THE EVENT OCCURRED DURING PATIENT USE; HOWEVER, NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22843002 ↗MalfunctionJan 11, 2024Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE CUFF OF TRACHEOSTOMY DIDN'T INFLATE. THE VIDEO PROVIDED BY THE CUSTOMER SHOWS PATIENT INVOLVEMENT. NO DETAIL OF PATIENT HARM PROVIDED IN THE FORM. EVENT OCCURRED IMMEDIATELY ON USE. EVENT OCCURRED IN THE HOSPITAL. THE ISSUE WAS REPORTED AS RESOLVED. CUSTOMER OPENED A NEW KIT OF THE SAME IEM NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18499017 ↗
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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