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Portex 100/110/085Recalls & 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
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315050817), received between Aug 8, 2018 and Aug 8, 2018 — classified as 1 injury.

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.

Most reported problems

Device problems

  • Gas/Air Leak1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 8, 2018Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED THAT AFTER 30 MINUTES USE OF A TRACHEAL TUBE, AIR LEAKAGE WAS OBSERVED FROM THE CUFF. THE FAULTY TUBE WAS EXCHANGED WITH A NEW ONE. THE TUBE WAS CHECKED IN ACCORDING TO THE INSTRUCTIONS FOR USE. POST-USE TESTING WAS DONE ON THE TUBE AND THE LEAK WAS CONFIRMED BY OBSERVING THE INFLATED CUFF PLACED IN WATER. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS INCIDENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7764602 ↗

Other Tube, tracheal (w/wo connector) devices

All Tube, tracheal (w/wo connector) devices →

Sources and updates

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