Medex MX448L60MGRecalls & 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
- 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 10351688507372), received between Jul 13, 2017 and Jul 13, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Disconnection1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2017Disconnection; Disconnection
IT WAS REPORTED THAT THE TUBING OF A MEDEX¿ MAGNUM¿ MICRO FLUID DELIVERY SYSTEM BECAME DISCONNECTED FROM THE PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER LINE (PICC). THE DISCONNECTION OCCURRED WHERE THE 3 WAY STOPCOCK CONNECTS. THE PICC LINE WAS PLACED IN THE PATIENT'S LEFT FOREARM, AND THE IV LUMEN DEVICE TYPE WAS SINGLE. THE TUBING HAD BEEN HANGING FOR 72 HOURS WITHOUT ANY DISCONNECTIONS, THE DISCONNECTION ONLY OCCURRED WHEN TRANSFERRING THE INFANT TO BE HELD BY ITS MOTHER. NEW TUBING WAS HUNG AND TOTAL PARENTERAL NUTRITION WAS RECONNECTED TO THE PATIENT. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6711914 ↗
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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 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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