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Portex C1038JRecalls & 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
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 05019315059585), received between Sep 15, 2022 and Mar 11, 2026 — classified as 2 malfunctions.

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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Disconnection1

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 11, 2026Disconnection

    IT WAS REPORTED DURING THE SURGERY, THE BREATHING FILTER ON THE SNAKE TUBE CAME OFF. THERE WAS NO FEELING OF LOOSENESS, BUT WITH THE CURRENT SPECIFICATION, THE LOOSENESS OCCURS NOTICEABLY MORE OFTEN. THE EVENT OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24571320 ↗
  • MalfunctionSep 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER NOTICED THE CONNECTOR WAS DETACHED FROM THE BREATHING BAG. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15426784 ↗

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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