Medex TF55Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688500311), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
Patient problems
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2025Defective Device
UTILIZING A TRIFUSE ATTACHED TO THE CENTRAL LINE TO INCREASE ACCESS FOR MULTIPLE DRIPS. BEDSIDE NURSE OBSERVED THAT THE PATIENT'S BLOOD PRESSURE DROPPED. BEDSIDE NURSE IMMEDIATELY ASSESSED THE PATIENT AND FOUND THE BED TO BE WET. BEDSIDE NURSE REALIZED TRIFUSE HAD MALFUNCTIONED. TRIFUSE WAS REMOVED IT, DRIPS RESTARTED AND MONITORED WHILE THE PATIENT RECOVERED.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 23050590 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.