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Portex 450965-NLRecalls & 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
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 15019315075971), received between Feb 19, 2020 and Feb 19, 2020 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Leak/Splash1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 19, 2020Leak/Splash; Leak/Splash

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® ANESTHESIA CIRCUIT WAS NOTED TO BE LEAKING AND NOT WORKING PROPERLY. THE PRODUCT WAS REPLACED WITH ANOTHER WITH NO REPORTED ADVERSE EFFECTS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9730097 ↗

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

All Circuit, breathing (w connector, adaptor, y piece) devices →

Sources and updates

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