Skip to content

Portex 100/179/060Recalls & 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315022104), received between May 4, 2019 and May 12, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Leak/Splash1

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.

  • InjuryMay 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    DEVICE ANALYSIS COMPLETED AND SUMMARY IN H10.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11813979 ↗
  • MalfunctionMay 4, 2019Leak/Splash; Leak/Splash

    INFORMATION WAS RECEIVED THAT DURING THE USE OF A SMITHS MEDICAL PORTEX CUFFED IVORY ENDOTRACHEAL TUBE, "THE CUSTOMER NOTICED BLOOD LEAKED SOMEWHERE IN THE TUBE". NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8580695 ↗

Other Tube, tracheal (w/wo connector) devices

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

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page