Medex MX450FLRecalls & 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
- 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 10351688507334), received between Aug 6, 2021 and Aug 6, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash3
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE END OF THE DEVICE HAS PULLED OFF MULTIPLE TIMES CAUSING FLUID INCLUDING BLOOD TO BE LOST.
Patient problems: Insufficient Information
MAUDE report 12291323 ↗MalfunctionAug 6, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE END OF THE DEVICE HAS PULLED OFF MULTIPLE TIMES CAUSING FLUID INCLUDING BLOOD TO BE LOST.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12291271 ↗MalfunctionAug 6, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE END OF THE DEVICE HAS PULLED OFF MULTIPLE TIMES CAUSING FLUID INCLUDING BLOOD TO BE LOST.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12291175 ↗
Other Tubing, fluid delivery devices
- High Pressure Tubing CMerit Medical Systems, Inc. · Tubing, fluid delivery1 recall0 reports
- High Pressure Tubing CMerit Medical Systems, Inc. · Tubing, fluid delivery1 recall0 reports
- Medex MX43660Icu Medical, Inc. · Tubing, fluid delivery27 reports
- Medex MX43860Icu Medical, Inc. · Tubing, fluid delivery13 reports
- Medex MX451FLIcu Medical, Inc. · Tubing, fluid delivery5 reports
- Medex MX452FLIcu Medical, Inc. · Tubing, fluid delivery5 reports
- 10 in. (25 cm) Q2 Checkmate extension set 9545Quest Medical Inc · Tubing, Fluid Delivery3 reports
- Medex MX458LIcu Medical, Inc. · Tubing, fluid delivery3 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.
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