Medex MX6812Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688506054), received between Jan 12, 2023 and Oct 27, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
- Fluid/Blood Leak1
- Leak/Splash1
- Obstruction of Flow1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Leak/Splash; Separation Problem; Leak/Splash; Separation Problem
IT WAS REPORTED THAT THEY HAVE THE SAME ISSUE WITH FOUR-WAY STOPCOCK EXTENSION WHICH THEY WERE EASILY ABLE TO DISCONNECT THE TWO PIECES, AND THEY ARE USED ON PRESSURIZED ARTERIAL LINES IN WHICH THEY CAN LOSE LARGE VOLUMES OF BLOOD IF NOT CAUGHT IN TIME. THERE IS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393674 ↗MalfunctionJan 12, 2023Fluid/Blood Leak; Obstruction of Flow; Connection Problem; Fluid/Blood Leak; Obstruction of Flow; Connection Problem
IT WAS REPORTED THAT THERE WAS AN EMERGENCY IN THE OPERATING ROOM, AND BLOOD COULD NOT PUMP THROUGH THE EXTENSION TUBING. THEY EXPERIENCED LEAKING AND WERE HARD TO CONNECT TO THE INSERTION PORT. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS, OR ADVERSE AFFECTS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16150634 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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