Medex MX412SLRecalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688507860), received between Dec 31, 2018 and May 8, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Gas/Air Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Fluid/Blood Leak
IT WAS REPORTED THAT ONE OF THE STOPCOCK CONNECTIONS BROKE, RESULTING IN THE LINE PULLING OUT FROM THE CONNECTION WHILE IN USE ON A PATIENT DURING CHEST TUBE DRAINAGE MONITORING. THE DAMAGED LINE WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123398 ↗MalfunctionApr 8, 2026Gas/Air Leak
IT WAS REPORTED THAT THE PATIENT'S CHEST TUBE HAD BEEN DISCONNECTED. THE TUBE WAS RECONNECTED, BUT IT DISCONNECTED TWICE MORE OVER THE NEXT THREE DAYS. WHEN THE WRITER SAW THE PATIENT, THE LINE WAS TAPED AT THE DISCONNECTION POINT. THE WRITER REMOVED THE TAPE AND FOUND THAT THE LINE ITSELF WAS BROKEN. THE DAMAGED LINE WAS REMOVED AND REPLACED. THERE WERE NO ADVERSE EVENTS WITH THE PATIENT'S CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817356 ↗MalfunctionDec 31, 2018Leak/Splash
IV CONTRAST WAS LEAKING AT THE COCKSTOP PORT, PATIENT DID NOT CONSUME ALL OF CONTRAST FOR TESTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8208386 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.