Portex 101/875/080Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517078077), received between Jul 18, 2024 and Mar 10, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Crack” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Crack3
- Suction Problem1
- Unintended Deflation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Hypoxia1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Crack
IT WAS REPORTED THAT THERE IS A CRACK IN THE SUCTION LINE AT THE BLUE PORT, AND IT WAS UNABLE TO CLEAR THE ABOVE-CUFF SECRETIONS. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560748 ↗MalfunctionMar 10, 2026Crack
IT WAS REPORTED THAT THERE IS A CRACK IN THE SUCTION LINE AT THE BLUE PORT, AND IT WAS UNABLE TO CLEAR THE ABOVE-CUFF SECRETIONS. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560743 ↗InjuryApr 17, 2025Crack; Crack
IT WAS REPORTED THAT THE BLUE PLASTIC SUCTIONED PORT WAS CRACKED. TRACH CHANGE PERFORMED ON THE PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.
Patient problems: Hypoxia
MAUDE report 21858850 ↗MalfunctionFeb 6, 2025Suction Problem; Suction Problem
IT WAS REPORTED THAT A CRACK WAS OBSERVED IN THE SUCTION PORT, AND THE CLINICIANS WERE UNABLE TO CLEAN LINE. THE TRACH WAS REMOVED AND REPLACED AND DISCARDED. DATE OF EVENT WAS 13-DEC-2024. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21326471 ↗InjuryJul 18, 2024Unintended Deflation; Unintended Deflation
IT WAS STATED THAT THE CUFF WAS NOT HOLDING AIR/PRESSURE AND AN EMERGENCY TRACH CHANGE WAS PERFORMED. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19777965 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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