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Portex 492804-NLRecalls & 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 10351688427465), received between Sep 15, 2022 and Sep 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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

  • Material Too Rigid or Stiff1

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.

  • MalfunctionSep 15, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

    IT WAS REPORTED THAT THE CIRCUITS ARE STIFF. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15427210 ↗

Other Circuit, breathing (w connector, adaptor, y piece) devices

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Sources and updates

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