Medex MX522SLRecalls & 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 10351688506818), received between Jul 13, 2022 and Jul 13, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STOPCOCK W/EXTENSION WAS BEING USED TO ADMINISTER CELLULAR THERAPY PRODUCTS AND WHEN REMOVED FROM THE LUMEN IT WAS HOOKED INTO, PART OF THE END OF THE MALE PIECE STAYED IN THE PATIENT'S LUMEN AND CAUSED THE LINE TO BE REPLACED. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 15008632 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.