Portex 100/322/100Recalls & reported problems
Icu Medical, Inc. · Class 1
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 15019315071430), received between Jan 27, 2022 and Jun 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. 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
- Device Dislodged or Dislocated2
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 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE COLORED PLASTIC INSERT FELL OUT WHEN AIRWAY WAS IN PATIENTS' MOUTH. THE AIRWAY WAS REMOVED AND REPLACED WITH A NEW AIRWAY. THE STAFF DISPOSED OF DEFECTIVE DEVICE, SO IT IS NOT AVAILABLE FOR EVALUATION. THE ITEM WAS REMOVED FROM PATIENTS' MOUTH AND REPLACED WITH A DIFFERENT AIRWAY. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566398 ↗MalfunctionJan 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS IN THE RECOVERY ROOM, NOT YET AWAKE BUT WAS PUSHING ON THE GUEDEL CANNULA IN THEIR MOUTH. THE RED TIP OF THE CANNULA, WHICH IS MOBILE, ENDED UP IN THE PATIENT'S MOUTH WHICH CAUSED A RISK OF SWALLOWING OR CHOKING ON IT. THE CUSTOMER STATED THE CANNULA DID NOT APPEAR TO BE DAMAGED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13366513 ↗
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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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