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
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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