Medex MX448HLMGRecalls & reported problems
Icu Medical, Inc. · Class 2
All models of Medex (98)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688507419), received between Jul 12, 2023 and Jul 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DOPAMINE TUBING WAS FOUND LEAKING FROM THE STOPCOCK. IT DID NOT SEEM TO BE LEAKING ABOVE THE STOPCOCK, FROM THE BAG OR FROM THE SYRINGE. THE TUBING SEEMED TO BE FILLED WITH BUBBLES AND UPON FURTHER INSPECTION, THE TUBING WAS WET AND THE LABEL ON THE TUBING WAS SATURATED WITH FLUID. THE DOPAMINE WAS ACTIVELY RUNNING AT 4MCG/KG/MIN AND IS UNKNOWN IF THE PATIENT WAS GETTING THE CORRECT DOSE DUE TO THE LEAK. THE PATIENT HAD AN ARTERIAL LINE AND REMAINED STABLE DURING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17310194 ↗
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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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