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Portex 66-1997Recalls & reported problems

Icu Medical, Inc. · Class 1

All models of Portex (409)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10788942619975), received between Oct 26, 2022 and Oct 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 16, 2026.

Most reported problems

Device problems

  • Component Missing1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 26, 2022Component Missing; Component Missing

    IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED NO PATIENT-SIDE CONNECTOR CAME WITH IT THE PRODUCT. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15674660 ↗

Other CONNECTOR, AIRWAY (EXTENSION) devices

All CONNECTOR, AIRWAY (EXTENSION) devices →

Sources and updates

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