Medex MX9342LRecalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10351688504166), received between Oct 29, 2019 and Jan 13, 2025 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Backflow” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Backflow1
- Disconnection1
- Fluid/Blood Leak1
- Fracture1
- Infusion or Flow Problem1
- Leak/Splash1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Low Blood Pressure/ Hypotension2
- Patient Problem/Medical Problem1
- Tachycardia1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2025Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak
IT WAS REPORTED THAT THE YELLOW 4-WAY STOPCOCK CONNECTED TO THE PATIENT'S IJ CENTRAL LINE BROKE IN HALF AND THE MULTIPLE MEDICATION THAT WERE INFUSING THROUGH THAT LUMEN/STOPCOCK WERE BACKFLOWING OUT OF THE BROKEN STOPCOCK ONTO THE BED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21143274 ↗MalfunctionFeb 20, 2024Fracture; Fracture
IT WAS REPORTED THAT THE 4-WAY STOPCOCK SNAPPED WHILE TURNING. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18743517 ↗MalfunctionJan 22, 2024
4-WAY STOPCOCK SNAPPED WHILE TURNING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18551822 ↗MalfunctionJan 11, 2024
WHILE TURNING THE PATIENT, THE YELLOW DOUBLE STOPCOCK DEVICE BECAME DISCONNECTED BETWEEN THE TWO STOPCOCKS. THREE VASOPRESSORS WERE INFUSING AT THE TIME AND THE NURSES INVOLVED IN THE TURN HAD TO QUICKLY GET ANOTHER CONNECTOR TO CONTINUE TO INFUSE VASOPRESSORS. THE PATIENTS BLOOD PRESSURE DID DROP AND VASOPRESSORS HAD TO BE TITRATED UP.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 18491012 ↗InjuryMar 5, 2020Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDEX STOPCOCKS BROKE IN HALF CAUSING A "DANGEROUS DROP IN BLOOD PRESSURE UNTIL A NEW DEVICE WAS LOCATED". THE REPORTER INDICATED THAT THE PATIENT WAS A VASOPRESSOR DEPENDENT. THE REPORTER ALSO INDICATED THAT SPILT WAS AT THE CONTACT POINT (GRAY/PURPLE CONNECTION POINT BETWEEN THE TWO YELLOW STOPCOCK VALVES). NO FURTHER ADVERSE EVENTS WERE REPORTED.
Patient problems: Low Blood Pressure/ Hypotension; Patient Problem/Medical Problem
MAUDE report 9793455 ↗MalfunctionOct 29, 2019Disconnection; Leak/Splash; Disconnection; Leak/Splash
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDEX STOPCOCK BECAME DISCONNECTED FROM THE PATIENT'S IV LINE, CAUSING IV FLUIDS AND BLOOD TO LEAK. THERE WAS A REPORTED DELAY IN SEDATION AND PAIN MEDICATION AS A RESULT OF THIS DISCONNECTIONS. THE PATIENT'S HEART RATE WAS OBSERVED TO GO FROM 170BPM TO 190BPM. SEDATION MEDICATION WAS GIVEN WHILE THE PATIENT WAS WAITING FOR THE CONTINUOUS SEDATION TO WORK. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.
Patient problems: Tachycardia
MAUDE report 9252617 ↗
Other Stopcock, i.V. Set devices
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
- 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
- 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.