Medex MX452FLRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10351688507273), received between Feb 16, 2022 and Feb 16, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE ITEM IS NOT WORKING CORRECTLY, BLOOD KEEPS LEAKING OUT; THERE IS NO STOPPING MECHANISM. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13545018 ↗MalfunctionFeb 16, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE ITEM IS NOT WORKING CORRECTLY, BLOOD KEEPS LEAKING OUT; THERE IS NO STOPPING MECHANISM. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13542106 ↗MalfunctionFeb 16, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE ITEM IS NOT WORKING CORRECTLY, BLOOD KEEPS LEAKING OUT; THERE IS NO STOPPING MECHANISM. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13542053 ↗MalfunctionFeb 16, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE ITEM IS NOT WORKING CORRECTLY, BLOOD KEEPS LEAKING OUT; THERE IS NO STOPPING MECHANISM. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13541988 ↗MalfunctionFeb 16, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE ITEM IS NOT WORKING CORRECTLY, BLOOD KEEPS LEAKING OUT; THERE IS NO STOPPING MECHANISM. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13541847 ↗
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- 10 in. (25 cm) Q2 Checkmate extension set 9545Quest Medical Inc · Tubing, Fluid Delivery3 reports
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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