Medex MX694RRecalls & 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 10351688505798), received between Aug 14, 2024 and Sep 17, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fluid/Blood Leak1
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.
MalfunctionSep 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE ROTATING ADAPTER WAS UNSEALED AND CONTRAST LEAKED OUT DURING INJECTION. THE ROTATING ADAPTER HAD BEEN PREVIOUSLY CHECKED AND DETERMINED TIGHT. THE PATIENT REQUIRED IMMEDIATE REPLACEMENT TO BE ABLE TO CONTINUE OPERATIONS. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20240230 ↗MalfunctionAug 14, 2024Break; Break
IT WAS REPORTED THAT THE CATHETER BROKE FROM THE CONNECTION AT THE SAME SPOT THREE TIMES. USED DIFFERENT CONNECTION TUBING AFTER THIRD FAILURE AND HAD SUCCESSFUL POWER INJECTION OF CONTRAST. THERE WAS A DELAY IN THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19986431 ↗
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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.
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