Medex MX4315LMRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688507686), received between Apr 4, 2025 and Apr 22, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- Low Blood Pressure/ Hypotension1
- No Clinical Signs, Symptoms or Conditions1
- Ventricular Fibrillation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE MANIFOLD ON A CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) PATIENT WAS FOUND TO HAVE A LEAK. THE PATIENT¿S BLOOD PRESSURE DROPPED SIGNIFICANTLY AND WENT INTO VENTRICULAR FIBRILLATION (V-FIB) WITHIN 15-20 MINUTES OF THE INCIDENT. THE THERAPIES USED ON THE PATIENT AT THE TIME OF THE EVENT WAS CARDIAC DRUGS.
Patient problems: Low Blood Pressure/ Hypotension; Ventricular Fibrillation
MAUDE report 21882938 ↗MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DEVICE WAS LEAKING IN MANIFOLDS DURING THE INFUSION WAS PERFORMED ON THE PATIENT. THE NURSE DISCOVERED THE LEAK WHEN THE PATIENT WAS DECOMPENSATED. THE PATIENT WAS EVENTUALLY PLACED ON VA ECMO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21777785 ↗
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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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