Portex 11-1010Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10788942110106), received between Aug 4, 2022 and Nov 22, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 reports).
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
- Component Missing2
- Detachment of Device or Device Component1
- Incomplete or Missing Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE SPACER THAT WAS SENT, WAS MISSING THREE PIECES. NO PATIENT INJURY REPORTED. LOT NUMBER WAS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18193652 ↗MalfunctionSep 13, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging
IT WAS REPORTED THAT THERE WAS A WHITE PIECE ON TOP OF THE BULB MISSING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15410614 ↗MalfunctionSep 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A DOSE INHALER DETACHED FROM THE BASE AT THE CONNECTION TO THE VENTILATION CIRCUIT MAKING IT DIFFICULT TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15409667 ↗MalfunctionAug 4, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THERE WERE MISSING PARTS FROM EACH END. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15163522 ↗
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- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 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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