Portex 66-2509Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10788942625099), received between Jan 6, 2023 and Feb 23, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
- Material Puncture/Hole1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT THE DEVICE WAS CONNECTED TO AN ANESTHESIA PATIENT CIRCUIT AND A LEAK WAS NOTICED ON THE PORT. IT WAS ALSO MENTIONED THAT THERE WAS A MELTED HOLE ON THE SWIVEL ADAPTOR. THERE WAS NO HARM OR DELAY IN THERAPY TO THE PATIENT SINCE THE ISSUE WAS CAUGHT IMMEDIATELY AND THE SET CHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16432684 ↗MalfunctionJan 6, 2023Material Separation; Material Separation
IT WAS REPORTED THAT THE DEVICE IS COMING APART. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16116270 ↗
Other CONNECTOR, AIRWAY (EXTENSION) devices
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- ErgoStar CM 55 MP01855Drägerwerk AG & Co. KGaA · Connector, Airway (Extension)1 recall10 reports
- ErgoStar CM 45 MP01845Drägerwerk AG & Co. KGaA · Connector, Airway (Extension)1 recall1 report
- ErgoStar CM 40 MP01840Drägerwerk AG & Co. KGaA · Connector, Airway (Extension)1 recall1 report
- Adaptors/Connectors S6411PWestmed, Inc. · Connector, Airway (Extension)1 recall0 reports
- Omnistream 011401Oridion Medical 1987 Ltd. · CONNECTOR, AIRWAY (EXTENSION)1 recall0 reports
- ErgoStar CM 60 MP01860Drägerwerk AG & Co. KGaA · Connector, Airway (Extension)1 recall0 reports
- Portex 66-1991Icu Medical, Inc. · CONNECTOR, AIRWAY (EXTENSION)8 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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