Portex 100/322/080Recalls & reported problems
Icu Medical, Inc. · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019315071416), received between Aug 12, 2020 and Dec 12, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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
- Disconnection3
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2024Disconnection; Disconnection
IT WAS REPORTED THAT THE GUEDEL DISENGAGED JUST AS THE "SNG" WAS BEING PUT ON.¿ THERE WERE NO REPORTED CONSEQUENCES ON THE PATIENT AS THE USER RECOVERED IT FROM THE MOUTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913559 ↗MalfunctionApr 22, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE GREEN RING CAME OUT OF THE TUBE AND WAS FOUND INSIDE OF PATIENT'S MOUTH. NO INJURY OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14186742 ↗MalfunctionAug 12, 2020Disconnection; Disconnection
CORRECTIVE INFORMATION TO BE SENT IN H10.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10397734 ↗MalfunctionAug 12, 2020Disconnection; Disconnection
INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX AIRWAY GUEDEL OROPHARYNGEAL WHEN PATIENT WAS COUGHING, THE GREEN TIP OF THE GUEDEL AIRWAY DISCONNECTED. THEY HAD TO CHANGE THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10396942 ↗
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- King LTS-D KLTSD422King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- GUEDEL AIRWAY, SIZE 000, ISO 3.5 1000035Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- Medline DYND300020PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300025PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300010PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.