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Portex 66-2504Recalls & reported problems

Icu Medical, Inc. · Class 1

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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10788942625044), received between Mar 2, 2023 and Mar 2, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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

  • Connection Problem1
  • Detachment of Device or Device Component1
  • Fitting Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionMar 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE CUSTOMER FOUND THE SEAL THAT HOLDS THE END-PIECE INTO PLACE CAN BE PULLED OFF. NO INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16474075 ↗
  • MalfunctionMar 2, 2023Fitting Problem; Connection Problem; Fitting Problem; Connection Problem

    IT WAS REPORTED THAT THE SEAL THAT HOLDS THE ONE END PIECE INTO PLACE CAN BE PULLED OFF. THE GIVEN PART NUMBER WAS (B)(4). THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT AS THIS WAS FOUND IN PRE-TEST.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16473675 ↗

Other CONNECTOR, AIRWAY (EXTENSION) devices

All CONNECTOR, AIRWAY (EXTENSION) devices →

Sources and updates

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