Medex MX934Z3LMRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10351688504159), received between Aug 1, 2017 and Sep 9, 2022 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Blocked Connection” (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
- Blocked Connection1
- Break1
- Crack1
- Leak/Splash1
- Material Fragmentation1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Low Blood Pressure/ Hypotension1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2022Blocked Connection; Blocked Connection
IT WAS REPORTED THAT DURING USE, THE DEVICE WAS BLOCKED AND USE WAS DISCONTINUED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15396837 ↗MalfunctionMar 4, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT DEBRIS WAS FOUND IN LINE WHILE CONNECTED TO PATIENT. MANIFOLD AND ALL TUBING CHANGED OUT. BLOOD HAD BACKED UP INTO TUBING. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13666987 ↗InjuryMay 22, 2020Break; Material Fragmentation; Break; Material Fragmentation
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDEX MANIFOLD SNAPPED AT THE CONNECTION PIECE. THE PATIENT WAS REPORTED TO BE RECEIVING VASOPRESSORS AT THE TIME OF BREAK LEADING TO THE PATIENT BECOMING HYPOTENSIVE. TITRATION OF VASOPRESSORS WAS INCREASED TO ACHIEVE THE ORDERED MEAN ARTERIAL PRESSURE (MAP) GOALS. THE UNIT WAS CHANGED OUT AND DISCARDED WITH NO FURTHER REPORTED ADVERSE EFFECTS.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 10082937 ↗InjuryAug 1, 2017Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT A MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCK LEAKED AND CRACKED WHEN NURSES HOOKED UP THE INTRAVENOUS TUBING. THE PRODUCT FAULT OCCURRED WHILE IN USE WITH A PATIENT. PATIENT RECEIVED A BOLUS OF PRESSORS TO IMPROVE BLOOD PRESSURE DUE TO THE INTERRUPTIONS IN THERAPY. NO PERMANENT INJURY WAS REPORTED, AND THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6758112 ↗
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
- 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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