Portex C45091711-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 15019315096303), received between Sep 14, 2022 and Sep 14, 2022 — 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 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 14, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BREATHING BAG RUPTURED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15417503 ↗
Other BAG, RESERVOIR devices
- VentStar Bag Set (P) 110 MP00384Drägerwerk AG & Co. KGaA · Bag, Reservoir2 recalls0 reports
- VentStar Bag Set (N) 110 MP00383Drägerwerk AG & Co. KGaA · Bag, Reservoir1 recall0 reports
- Portex 101/870/070CZIcu Medical, Inc. · BAG, RESERVOIR28 reports
- WalkMed® 204821Walkmed Technologies, LLC · Bag, Reservoir4 reports
- Portex C45031768D-NLIcu Medical, Inc. · BAG, RESERVOIR3 reports
- CARDINAL HEALTH BB3000LFBCardinal Health 200, LLC · BAG, RESERVOIR2 reports
- Portex C37201370JIcu Medical, Inc. · BAG, RESERVOIR2 reports
- Portex C49201668D-NLIcu Medical, Inc. · BAG, RESERVOIR2 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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