Portex Z110-14Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315034237), received between Sep 4, 2022 and Sep 4, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Disconnection1
- Fluid/Blood Leak1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN LIQUID IS INJECTED INTO THE DEVICE NOZZLE NOTHING REACHES THE PATIENT. ALL THE LIQUID FLOWS ONTO THE PATIENT. GIVEN THE PROBLEM WITH THE PRODUCT IT WAS NECESSARY TO DISCONNECT THE PATIENT FROM THE VENTILATION CIRCUIT IN ORDER TO MAKE THE INSTALLATION EFFECTIVE. THIS CAUSED DE-SATURATION AND LOSS OF EXPIRATORY PRESSURE IN THE PATIENT'S LUNGS. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20139922 ↗MalfunctionOct 26, 2022Break; Break
IT WAS REPORTED THAT THE CONNECTOR PIECE THAT GOES INTO THE VENTILATOR CIRCUIT BROKE WHILE IN USE ON A PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15674663 ↗MalfunctionSep 16, 2022Disconnection; Disconnection
IT WAS REPORTED THAT THE CLOSED ASPIRATION SYSTEM SPONTANEOUSLY DISCONNECTS ON SIDE OF THE BREATHING CIRCUIT. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15436614 ↗MalfunctionSep 4, 2022Break; Break
IT WAS REPORTED THAT SUCTION CATHETER WAS BROKEN IN THE "T" AREA. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15353886 ↗MalfunctionSep 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT PATIENT DESATURATED THROUGH THE NIGHT. OXYGENATION IMPROVED BRIEFLY AFTER CLOSED SUCTIONING. THICK BLOOD CLOTS ASPIRATED WHEN SWITCH TO OPEN SUCTIONING. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15353849 ↗
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- HUDSON RCI HUD05014Medline Industries, Inc. · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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