Medex MX4342LMRecalls & 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 10351688507631), received between Nov 19, 2025 and Dec 2, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (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.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device1
- Fluid/Blood Leak1
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.
MalfunctionDec 2, 2025Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT WHEN THE NURSE WENT TO DRAW LABS AT 0400, 1ML WAS FLUSHED, THEN, WHILE DRAWING BACK A WASTE FROM OPEN PUSH PORT, ONLY AIR WAS BEING PULLED BACK. LINES WERE PROMPTLY REMOVED AND FLUSHED A SMALL AMOUNT AT LUMEN HUB TO ENSURE LUMEN WAS STILL PATENT. NEW LINE WAS STRUNG UP AND HUB WAS CHANGED STERILELY. THE CAP OR CLAVE ALSO CAME OFF WITH SYRINGE FROM THE STOPCOCK PORT. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692496 ↗MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A LEAKAGE IN BETWEEN PLASTIC OF STOPCOCK. SEDATIVES INFUSING, CAUSING PROPOFOL TO LEAK. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23595031 ↗
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- 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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