Portex 370900-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 15019315076169), received between Apr 4, 2022 and Apr 4, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Decrease in Pressure” (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
- Decrease in Pressure1
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionApr 4, 2022Decrease in Pressure; Incorrect, Inadequate or Imprecise Result or Readings
DISPOSABLE ANESTHESIA BREATHING CIRCUIT FAILED COMPLIANCE TESTS MULTIPLE TIMES AFTER USING 3 CIRCUITS FROM SAME LOT NUMBER. WHEN MANUAL LEAK TEST PERFORMED, CIRCUIT WOULD ONLY HOLD PRESSURE IF APL WAS SET TO 40CMH2O OR GREATER. WHEN CIRCUIT WAS RELEASED BELOW 40CMH2O BREATHING CIRCUIT WOULD NOT REMAIN PRESSURIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13994664 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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