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Portex 198-39LRecalls & reported problems

Icu Medical, Inc. · Class 2

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 15019315058639), received between Aug 20, 2018 and Apr 7, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Leak/Splash1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 7, 2021Leak/Splash; Leak/Splash

    INVESTIGATION COMPLETED AND SUMMARY IN H 10.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11632256 ↗
  • MalfunctionAug 20, 2018Material Twisted/Bent; Material Twisted/Bent

    INFORMATION WAS RECEIVED INDICATING THAT THE ORIENTATION PORT OF A SMITHS MEDICAL PORTEX® ENDOTRACHEAL TUBE WAS NOTED TO BE INCLINED MORE SHARPLY. THERE WERE NO REPORTED ADVERSE EFFECTS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7799659 ↗

Other TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) devices

All TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.