Medex MX613HRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 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 10351688506290), received between Feb 23, 2022 and Jun 19, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow2
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.
MalfunctionJun 19, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT DURING LINE CHANGE, THEY WERE UNABLE TO CLEAR ANY FLUID THROUGH THE TRIFUSE. ANOTHER TRIFUSE WAS DROPPED BY ANOTHER COWORKER WHICH WORKED APPROPRIATELY. UPON THERE INSPECTION FOLLOWING LINE CHANGE, ORIGINAL TRIFUSE WAS NOTED NOT TO HAVE AN OPENING AT THE END. THE 3 PORTS WERE OPEN BUT THE END OF THE TRIFUSE WAS SEALED SHUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293953 ↗MalfunctionFeb 23, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THE DEVICE'S IV LIPID FILTER IS NOT ALLOWING LIPIDS TO PASS THROUGH FROM IV TUBING INTO THE FILTER CHANGING THE FILTER DID NOT FIX THE ISSUE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13586691 ↗
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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 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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