Portex 450964-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 15019315075957), received between Jun 19, 2025 and Jun 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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.
Reports received per month
Most reported problems
Device problems
- Contamination1
- Moisture Damage1
- Particulates1
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.
MalfunctionJun 19, 2025Contamination; Moisture Damage; Particulates; Contamination; Moisture Damage; Particulates
IT WAS REPORTED THAT THERE WERE MOISTURE DROPLETS ALREADY IN THE FILTERS AND PLASTIC ASSEMBLY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22290109 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page