Medex MX693RRecalls & 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 10351688505811), received between Apr 19, 2021 and Apr 19, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (2 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.
Most reported problems
Device problems
- Insufficient Flow or Under Infusion2
- Pressure Problem2
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.
MalfunctionApr 19, 2021Insufficient Flow or Under Infusion; Pressure Problem; Insufficient Flow or Under Infusion; Pressure Problem
INFORMATION RECEIVED A INTERVENTIONAL IMAGING/MEDEX HIGH PRESSURE TUBING MALFUNCTIONED. THE REPORT INDICATED THAT ON TWO DIFFERENT OCCASIONS THE TUBING RUPTURED WHEN DOING PUMP PRESSURE INJECTION DURING A PROCEDURE. RATED FOR 900PSI, WERE USING 700-800 PSI. NO PATIENT INJURY DURING PROCEDURE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11685834 ↗MalfunctionApr 19, 2021Insufficient Flow or Under Infusion; Pressure Problem; Insufficient Flow or Under Infusion; Pressure Problem
INFORMATION RECEIVED A INTERVENTIONAL IMAGING/MEDEX HIGH PRESSURE TUBING MALFUNCTIONED. THE REPORT INDICATED THAT ON TWO DIFFERENT OCCASIONS THE TUBING RUPTURED WHEN DOING PUMP PRESSURE INJECTION DURING A PROCEDURE. RATED FOR 900PSI, WERE USING 700-800 PSI. NO PATIENT INJURY DURING PROCEDURE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11685527 ↗
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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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