Portex 4909ERecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 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 10351688076083), received between Aug 31, 2022 and Mar 12, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Disconnection2
- Break1
- Complete Blockage1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Complete Blockage
IT WAS STATED THAT THE CATHETER CONNECTOR APPEARED TO BE OBSTRUCTED AND UNABLE TO INJECT MEDICATIONS THROUGH CONNECTOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24581307 ↗MalfunctionJun 11, 2024Disconnection; Disconnection
IT WAS REPORTED THAT THE CATHETER CAME APART FROM THE CONNECTOR TWICE. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR INVESTIGATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19510467 ↗MalfunctionJun 11, 2024Disconnection; Disconnection
IT WAS REPORTED THAT THE CATHETER CAME APART FROM THE CONNECTOR TWICE. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR INVESTIGATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19510309 ↗MalfunctionOct 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS AN EPIDURAL DISCONNECT WITH THE NEW INDIVIDUALLY-PACKAGED CONNECTORS. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15591064 ↗MalfunctionAug 31, 2022Break; Break
IT WAS REPORTED THAT THE SUSPECT DEVICE WAS DAMAGED AFTER THE USER OPENED THE UNIT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327804 ↗
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- BD Luer-Lok, BD Glaspak 405735Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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