Medex MX5341LNRecalls & 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 10351688506771), received between May 22, 2017 and Jan 10, 2024 — 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
- Material Separation1
- Separation Problem1
Patient problems
- Insufficient Information1
- Seizures1
- Underdose1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2024Fluid/Blood Leak; Material Separation; Separation Problem; Fluid/Blood Leak; Material Separation; Separation Problem
IT WAS REPORTED THAT DURING AN INJECTED SCAN, THE WHITE PART OF THE "TAP" DETACHED, CAUSING THE IODINE TO SPILL ONTO THE SCAN TABLE. THIS CAUSED A 3-4 MINUTE DELAY IN PERFORMING THE DIAGNOSTIC SCAN (HEMATOMA ON LEFT LOWER LIMB). ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18488343 ↗InjuryMay 22, 2017Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A MEDEX¿ SMALL BORE STOPCOCK WAS IN USE WITH A PATIENT WHEN IT WAS OBSERVED THAT THERE WAS MEDICATION LEAKING. THE PATIENT WAS ASSESSED AT 8:00 AM AND THE NURSE OBSERVED THAT THERE WAS A LARGE AMOUNT OF FLUID UNDER THE PATIENT'S RIGHT LEG ON THE SHEETS. THE PATIENT WAS BEING INFUSED WITH PROPOFOL THROUGH THE PATIENT'S RIGHT FEMORAL CENTRAL VENOUS CATHETER (CVC). THE CVC LINE WAS ATTACHED TO A STOPCOCK, WHICH ALSO MANAGED CONTINUOUS FENTANYL AND LEVOPHED COMBINATION DELIVERY. ATTACHMENTS WERE INSPECTED AND WERE FOUND TO BE SECURE AND WITHOUT LEAKS. IT WAS OBSERVED THAT THE BACK OF THE STOPCOCK BUNDLE HAD PROPOFOL RESIDUE ON IT AND WAS CONFIRMED WITH A CHLORHEXIDINE GLUCONATE WIPE TO CLEAN THE AREA. AFTER THE AREA WAS CLEANED, IT WAS OBSERVED THAT WHITE FLUID APPEARED IN LARGE DROPS. THE PATIENT HAD SEIZURE ACTIVITY AT 6:00 AM ON THE NEXT DAY DUE TO THE INCIDENT AND PROPOFOL INFUSION DOSAGE WAS INCREASED TO TREAT THE SEIZURE ACTIVITY. NO PERMANENT INJURY WAS REPORTED.
Patient problems: Seizures; Underdose
MAUDE report 6582892 ↗
Other Stopcock, i.V. Set devices
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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
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- 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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