Portex 66-2504Recalls & 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 10788942625044), received between Mar 2, 2023 and Mar 2, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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
- Connection Problem1
- Detachment of Device or Device Component1
- Fitting Problem1
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.
MalfunctionMar 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CUSTOMER FOUND THE SEAL THAT HOLDS THE END-PIECE INTO PLACE CAN BE PULLED OFF. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16474075 ↗MalfunctionMar 2, 2023Fitting Problem; Connection Problem; Fitting Problem; Connection Problem
IT WAS REPORTED THAT THE SEAL THAT HOLDS THE ONE END PIECE INTO PLACE CAN BE PULLED OFF. THE GIVEN PART NUMBER WAS (B)(4). THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT AS THIS WAS FOUND IN PRE-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16473675 ↗
Other CONNECTOR, AIRWAY (EXTENSION) devices
- Flex Extenders 7-5132Westmed, Inc. · Connector, Airway (Extension)1 recall18 reports
- 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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