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Medex MX4710Recalls & reported problems

Icu Medical, Inc. · Class 1

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 10351688507020), received between Sep 9, 2022 and Sep 12, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

Most reported problems

Device problems

  • Leak/Splash2
  • Pressure Problem1

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.

  • MalfunctionSep 12, 2022Leak/Splash; Pressure Problem; Leak/Splash; Pressure Problem

    IT WAS REPORTED THAT THE PRODUCT LEAKED AND THE REQUIRED PRESSURE FOR USE WAS NOT REACHED. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15401709 ↗
  • MalfunctionSep 9, 2022Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE PRODUCT LEAKED AND THE REQUIRED PRESSURE FOR USE WAS NOT REACHED. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15396848 ↗

Other INFUSOR, PRESSURE, FOR I.V. BAGS devices

All INFUSOR, PRESSURE, FOR I.V. BAGS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.