Medex MX5096020MGRecalls & 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 10351688506832), received between Mar 17, 2017 and Mar 17, 2017 — 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 Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2017Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING PATIENT USE OF THE MEDEX¿ MANGUM¿ MICRO FLUID DELIVERY SYSTEM, THE BONDED HUB WAS LEAKING. ACCORDING TO THE REPORT THE LEAK WAS LOCATED AT THE HUB THAT WAS CLOSEST TO THE INTRAVENOUS SYRINGE WHICH CONTAINED A DOPAMINE INFUSION. IT WAS REPORTED THAT LIPIDS "AND OTHER IVF?" HAD BACKED UP INTO THE SYRINGE AND WAS DRIPPING FROM THE HUB. IT WAS NOTED THAT THE CREVICE UNDER THE SYRINGE WAS FULL OF FLUID AND A MODERATE AMOUNT OF FLUID WAS OBSERVED UNDER THE INTRAVENOUS PUMP AS WELL. ACCORDING TO THE REPORTER, THE DEVICE WAS PATIENT USE FOR HOURS PRIOR TO THE OBSERVED EVENT; HOWEVER, THE FULL LENGTH OF TIME WAS UNKNOWN. NO PATIENT INJURY OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THE REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6415260 ↗
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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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