Portex 101/561/090Recalls & 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
- 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 15019517103380), received between Jun 4, 2024 and Jun 12, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
- Inadequacy of Device Shape and/or Size1
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.
MalfunctionJun 12, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE THAT IS PURPLE, IS THE WRONG SIZE AND DOES NOT PROTRUDE FROM THE TRACHEOSTOMY TUBE. IT WAS THEREFORE IMPOSSIBLE TO INSERT THE TUBE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25482878 ↗MalfunctionJun 4, 2024Defective Device; Defective Device
IT WAS REPORTED THAT DURING A PERCUTANEOUS DILATATION TRACHEOSTOMY, THE TRACHEOSTOMA COULD NOT BE INSERTED WITH THE THIN WHITE DILATOR PROVIDED AFTER DILATATION WITH THE LARGE DILATOR, AS THE INNER OPENING OF THE INSERTION AID (VIOLET) WAS NOT SUFFICIENTLY CONTINUOUS. AFTER INSERTING THE GUIDE WIRE AND WHITE KINK PROTECTION, THE TRACHEOSTOMY TUBE WITH THE PURPLE-COLORED INTRODUCER WAS TO BE INSERTED. THIS WAS NOT POSSIBLE AS THE WHITE ANTI-KINK PROTECTION DID NOT FIT THROUGH THE PURPLE-COLORED INTRODUCER (BOTTLENECK). AFTER REMOVING THE BEND PROTECTION, ONLY THE GUIDE WIRE COULD BE THREADED THROUGH THE INTRODUCER, SO THAT THE TRACHEOSTOMY TUBE COULD STILL BE INSERTED. DUE TO THE EVENT, THE INSTALLATION OF THE TK WAS SOMEWHAT DELAYED. ACCORDING TO THE DOCTOR, THERE WERE NO PROBLEMS FOR THE PATIENT (SUFFICIENT OXYGENATION AT ALL TIMES). THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENTS WERE REPORTED. NO FURTHER INFORMATION ABOUT THE EVENT IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19459892 ↗
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- Bivona 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 670180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall140 reports
- Bivona 670170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall10 deaths132 reports
- Shiley 6CN75RCovidien LP · Tube tracheostomy and tube cuff1 recall1 death121 reports
- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 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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