Medex MX4312LRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688507754), received between Feb 8, 2018 and Feb 8, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Improper Flow or Infusion” (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
- Improper Flow or Infusion1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 8, 2018Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT A PATIENT STOPPED RECEIVING EPINEPHRINE DURING USE OF A MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCK. INITIALLY, THE STAFF THOUGHT THE CONNECTION OF THE STOPCOCK TO THE CLAVE HAD A CRACK. THE STOPCOCK DID NOT CONNECT EASILY, BUT THERE DID NOT APPEAR TO BE A PROBLEM. DURING USE, BLOOD BACKED UP INTO INFUSION PORT WHEN RUNNING SEDATION AND EPINEPHRINE. PATIENT WAS NOT RECEIVING EPINEPHRINE AND ENDED IN CARDIAC ARREST REQUIRING CPR FOR TWO MINUTES. IT WAS REPORTED THERE WAS NO ONGOING HARM TO THE PATIENT RELATED TO THE EVENT.
Patient problems: Cardiac Arrest
MAUDE report 7250731 ↗
Other Stopcock, i.V. Set devices
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- 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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