Medex MX4341LRecalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10351688507648), received between Aug 2, 2018 and May 7, 2026 — classified as 1 injury, 22 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (10 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow10
- Fluid/Blood Leak6
- Leak/Splash4
- Physical Resistance/Sticking3
- Break1
- Crack1
- Fitting Problem1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information3
- Low Blood Pressure/ Hypotension1
- No Information1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Fluid/Blood Leak
IT WAS STATED THAT PATIENT¿S CVC RED LUMEN STARTED BACKING UP BLOOD AND STARTED LEAKING AT IN THE STOPCOCK PLASTIC AND FROM THE HUB BETWEEN THE STOPCOCK AND THE EXTENSION. CONNECTIONS WERE CHECKED AND WERE TIGHT PRIOR TO LEAKING EPISODE AS WELL AS DURING THE LEAKAGE. THERE WAS ALSO AIR IN THE LINE BETWEEN THE LINE EXTENSION AND THE CAP AT THE CVC HUB. THE TUBING IS CHANGED. THERE WAS NO DELAY. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114220 ↗MalfunctionApr 20, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT HAD A DOUBLE STOPCOCK USED FOR DRAWING LABS FROM THE PICC LINE AND AFTER LABS WERE DRAWN AND ASPIRATED FROM THE CLOSEST STOPCOCK, BLOOD BEGAN SPRAYING DUE TO A HOLE IN THE STOPCOCK. PER REPORTER, THE NURSE INDICATED THE LEAK APPEARED TO OCCUR WHERE THE STOPCOCK TURNED, BEFORE THE CAP, AND THAT THE CAP WAS TIGHT AND THE LEAK APPEARED TO BE HIGH-PRESSURE, LIKELY FROM A SMALL HOLE. NO PATIENT HARM OCCURRED OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24930212 ↗MalfunctionApr 25, 2025Fitting Problem; Fitting Problem
IT WAS REPORTED THAT LUER LOCK IS SLIPPING WITH THE SYRINGE. THE REPORTER STATED WHEN THEY PLACED A SYRINGE ON THE END AND TWISTED TO LOCK IN PLACE, THE LUER LOCK KEPT CLICKING AND NEVER TRULY LOCKED THE SYRINGE IN PLACE. PATIENT INVOLVEMENT WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909508 ↗MalfunctionJun 2, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THERE WERE "A FEW BREAKS" IN THE MIDDLE OF A PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER AS IT WAS DISCOVERED PRIOR TO ADMINISTERING CHEMOTHERAPY DRUGS. THE ISSUE HAS OCCURRED WITH MULTIPLE PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17052835 ↗MalfunctionMar 6, 2023Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT THE DEVICE IS UNABLE TO RUN IV FLUIDS TO GRAVITY WITH STOPCOCK IN-SITU. LIMITS IV FLOW. ALSO LOTS OF RESISTANCE WHEN FLUSHING VIA SIDE PORT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16487995 ↗MalfunctionMar 6, 2023Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT THE DEVICE IS UNABLE TO RUN IV FLUIDS TO GRAVITY WITH STOPCOCK IN-SITU. LIMITS IV FLOW. ALSO LOTS OF RESISTANCE WHEN FLUSHING VIA SIDE PORT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16487765 ↗MalfunctionMar 2, 2023Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT THE DEVICE IS UNABLE TO RUN IV FLUIDS TO GRAVITY WITH STOPCOCK IN-SITU. LIMITS IV FLOW. ALSO LOTS OF RESISTANCE WHEN FLUSHING VIA SIDE PORT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16473338 ↗MalfunctionMar 30, 2022No Flow; No Flow
IT WAS REPORTED THAT WHILE INJECTING A PATIENT FOR AN EXAM THE 3-WAY STOPCOCK STOPPED WORKING AND WOULD NOT LET THE REPORTER CONTINUE TO INJECT RADIOPHARMACEUTICAL. IT CAUSED CONTAMINATION OF THE RADIOPHARMACEUTICAL. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13954265 ↗MalfunctionFeb 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE DEVICE'S 3-WAY STOP WAS LEAKING WHILE GIVING THE INJECTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13586157 ↗InjuryFeb 18, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE 3WAY STOPCOCK STARTED LEAKING WHILE IN USE OF IV MEDICATIONS. NO ADDITIONAL INFORMATION.
Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions
MAUDE report 13563216 ↗MalfunctionFeb 10, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE STOPCOCK LEAKS FLUID THAT PASSED THROUGH IT. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13507367 ↗MalfunctionJan 18, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE STOPCOCK PRIMED AND ADDED TO PRIMARY LINE. FREE FLOWS WELL BUT ONCE HOOKED UP TO PUMP AND PUMP PROGRAMMED READS DOWNSTREAM OCCLUSION AND INCREASED PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13282551 ↗MalfunctionJan 18, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE STOPCOCK PRIMED AND ADDED TO PRIMARY LINE. FREE FLOWS WELL BUT ONCE HOOKED UP TO PUMP AND PUMP PROGRAMMED READS DOWNSTREAM OCCLUSION AND INCREASED PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13282512 ↗MalfunctionJan 18, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE STOPCOCK PRIMED AND ADDED TO PRIMARY LINE. FREE FLOWS WELL BUT ONCE HOOKED UP TO PUMP AND PUMP PROGRAMMED READS DOWNSTREAM OCCLUSION AND INCREASED PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13282495 ↗MalfunctionJan 18, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE STOPCOCK PRIMED AND ADDED TO PRIMARY LINE. FREE FLOWS WELL BUT ONCE HOOKED UP TO PUMP AND PUMP PROGRAMMED READS DOWNSTREAM OCCLUSION AND INCREASED PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13282466 ↗MalfunctionJan 18, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE STOPCOCK PRIMED AND ADDED TO PRIMARY LINE. FREE FLOWS WELL BUT ONCE HOOKED UP TO PUMP AND PUMP PROGRAMMED READS DOWNSTREAM OCCLUSION AND INCREASED PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13282370 ↗MalfunctionJan 18, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE STOPCOCK PRIMED AND ADDED TO PRIMARY LINE. FREE FLOWS WELL BUT ONCE HOOKED UP TO PUMP AND PUMP PROGRAMMED READS DOWNSTREAM OCCLUSION AND INCREASED PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13282332 ↗MalfunctionJan 18, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE STOPCOCK PRIMED AND ADDED TO PRIMARY LINE. FREE FLOWS WELL BUT ONCE HOOKED UP TO PUMP AND PUMP PROGRAMMED READS DOWNSTREAM OCCLUSION AND INCREASED PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13282312 ↗MalfunctionJan 7, 2022Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT TT WAS THEN DISCOVERED THAT THERE WAS A CRACK IN THE 3-WAY STOP COCK THROUGH WHICH THE MEDICATION WAS RUNNING, AND THE MEDICATION WAS LEAKING ONTO THE BED. THE STOP-COCK WAS CHANGED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13192783 ↗MalfunctionJan 7, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SUBSTITUTION 4 WAY STOPCOCK DEVICE LEAKS WHEN ATTACHED TO 7" SMALLBORE PRESSURE INFUSION SET, LEAKING WHERE ONE ATTACHES TO THE OTHER / 1/3 OF PATIENTS DOSE LOST (LEAKED OUT) PATIENT INJECTED WITH MORE TO GET DESCRIBED DOSE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13192487 ↗MalfunctionJan 7, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE STOPCOCK LEAKS FLUID THAT PASSED THROUGH IT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13192271 ↗MalfunctionJan 5, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ABOUT 50-60% OF THE TIME THIS PRODUCT DOES NOT WORK BECAUSE IT LEAKS. IT WILL NOT ALLOW ANY FLUIDS THROUGH ONCE ATTACHED TO AN IV PORT. LUER LOCK, STRIPS VERY EASILY THEREFORE MAKING IT UNUSABLE. NO PATIENT INVOLVEMENT OR PATIENT INJURY WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13169891 ↗MalfunctionAug 2, 2018Fluid/Blood Leak
WHILE CONNECTED TO THE PAIN PUMP TUBING, NOTED THE PORTS ON THE STOPCOCK WERE LEAKING.
Patient problems: No Information
MAUDE report 7742158 ↗
Other Stopcock, i.V. Set devices
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- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.