Portex VP1343Recalls & 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
- 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 15019517162318), received between Sep 26, 2022 and Sep 26, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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.
Most reported problems
Device problems
- Component Missing1
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 26, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THERE SHOULD HAVE BEEN TWO BREATHING FILTERS IN THE CIRCUIT; BUT INSTEAD, THERE HAS BEEN ONLY ONE RECEIVED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15487079 ↗
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- Ventlab BT2034Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT3034Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4024Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4013Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4019Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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