Medex MX4311LRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688507761), received between Mar 14, 2023 and Jul 9, 2025 — classified as 2 malfunctions.
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
- Crack1
- Leak/Splash1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED THAT WHEN THE SITE WAS USING 2 SYRINGES THAT WERE SCREWED INTO THE STOPCOCK, IT SUDDENLY WENT LOOSE AND SALINE FROM THE SYRINGE FELL OFF FROM THE STOPCOCK. THERE WAS PATIENT INVOLVEMENT, BUT THERE WERE NO REPORTS OF THE PATIENT BEING HARMED/INJURED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22457855 ↗MalfunctionMar 14, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE DIAL WAS BROKEN OR CRACKED. DRUGS WERE LEAKING OUT, NOT GETTING TO PATIENT, AND EVENTUALLY BLOOD "BACKED UP OUT THE PIP" AND STARTED DRIPPING ONTO THE FLOOR. THERE HAS BEEN NO REPORT OF PATIENT INJURY, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16540926 ↗
Other Stopcock, i.V. Set devices
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- IV Administration Set 490432B. Braun Medical Inc. · Stopcock, i.V. Set1 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 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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