Medex MX2341LRecalls & 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
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10351688508324), received between Feb 8, 2018 and Sep 29, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak3
- Air/Gas in Device2
- Detachment of Device or Device Component2
- Backflow1
- Contamination1
- Crack1
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Blood Loss1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937298 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931964 ↗MalfunctionSep 28, 2026Backflow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923282 ↗MalfunctionSep 25, 2026Air/Gas in Device
It was reported that air was observed entering the line of the ULTRA¿ 4-Way Stopcock with Swivel Male Luer Lock, despite the connections being reported as secure. There was patient involvement; however, no patient harm or adverse event was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903500 ↗MalfunctionSep 25, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902236 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863041 ↗MalfunctionMay 15, 2025Contamination; Contamination
IT WAS REPORTED THAT THERE WAS A PARTICLE OF COMPONENT IN THE DEVICE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22027049 ↗MalfunctionAug 26, 2024Disconnection; Disconnection
GCM RECEIVED AND REVIEWED EMAIL VIA SERVICE CLOUD ON 5-AUG-2024 FROM (B)(6), REGARDING AN ULTRA(TM) 4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK 50/CA WITH ITEM NUMBER MX2341L LOT NUMBER 4470067. IT WAS STATED THAT THE STOPCOCKS ON 1 LUMEN OF PATIENT'S PICC LINE CAME DISCONNECTED. UPON DISCOVERY, PROMPTLY NOTIFIED PICC REGISTERED NURSE AND TROUBLESHOOTED. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR INVESTIGATION. SAMPLE PHOTOS WERE PROVIDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED. (B)(6) 2024. UPDATE: GCM RECEIVED AN EMAIL ON 9-AUG-2024 FROM (B)(6) INFORMING THAT THE PRODUCT WAS THROWN OUT AND IS NOT AVAILABLE. THE EVENT OCCURRED ON (B)(6) 2024 DURING INFUSION IN THE NICU. THE OUTCOME OF THE EVENT WAS RESOLVED, A HEPARIN FLUSH THROUGH THE PICC LINE WAS GIVEN AND STOPCOCKS WERE REMOVED. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED. (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20070965 ↗MalfunctionOct 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE 4- WAY STOPCOCK KEPT DISCONNECTING FROM THE IV LINE ALTHOUGH THE NURSE SCREWED IT IN SECURELY. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15679554 ↗MalfunctionOct 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A 4-WAY STOPCOCK KEPT DISCONNECTING FROM THE IV LINE; THE NURSE HAD SCREWED IT IN SECURELY. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15677094 ↗InjuryFeb 8, 2018Crack; Crack
IT WAS ADDITIONALLY REPORTED THAT THE INTERVENTION PROVIDED TO THE PATIENT WAS INTUBATION, BLOOD TRANSFUSION, AND A TRANSFER TO HIGHER LEVEL OF CARE. THE OUTCOME OF THE EVENT IS UNKNOWN.
Patient problems: Blood Loss
MAUDE report 7252515 ↗
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page