Medex MX493Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10351688506917), received between May 18, 2022 and Jul 20, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Leak/Splash2
- Break1
- Contamination /Decontamination Problem1
- Insufficient Flow or Under Infusion1
- Loose or Intermittent Connection1
- Pumping Stopped1
Patient problems
- Insufficient Information2
- Chemical Exposure1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2022Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Insufficient Flow or Under Infusion
IT WAS REPORTED VIA MEDWATCH NUMBER (B)(4): PATIENT STATED THAT THEY NOTICED WETNESS IN THE BLACK BAG CONTAINING SOLUTION BAG AND PUMP. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15066395 ↗MalfunctionJun 16, 2022Fluid/Blood Leak; Contamination /Decontamination Problem
PATIENT CALLED CLINIC STATING SHE NOTICED WETNESS IN BLACK BAG CONTAINING 5FU (FLUOROURACIL) BAG AND PUMP. SHE NOTICED THIS WHEN SHE WOKE UP AT 10:30. THE TUBING FROM 5FU BAG TO PUMP TUBING WAS DISCONNECTED. SHE RECONNECTED TUBING AND CALLED CLINIC. THERE WAS WHITE POWDER ON BLACK POUCH.
Patient problems: Chemical Exposure
MAUDE report 14711933 ↗MalfunctionMay 19, 2022Leak/Splash; Loose or Intermittent Connection
PATIENT CAME TO THE CLINIC FOR 5FU INFUSION PUMP DISCONNECT. RN NOTICED WHITE RESIDUE ON BLACK POUCH AND COMPLETED INFUSION BAG. TUBING CONNECTER BETWEEN BAG AND TUBING WAS LOOSE. ADAPTER (MEDEX DOUBLE MALE LUER LOCK (MX493)) BETWEEN THE MEDICATION BAG AND THE CADD PUMP TUBING. IT IS BELIEVED THE LEAKING WAS OCCURRING AT THE ADAPTER SITE.
Patient problems: Insufficient Information
MAUDE report 14436160 ↗MalfunctionMay 18, 2022Break; Leak/Splash; Pumping Stopped
PATIENT CAME TO CLINIC FOR 5FU PUMP DISCONNECTION. UPON ASSESSMENT 5FU PUMP STOPPED WITH 1.8 ML REMAINING PER SCREEN. STATUS POST OPENING BAG, CONNECTION FROM 5FU CARTRIDGE (PUMP) TO CHEMOTHERAPY INFUSION BAG HAD BROKEN AND LEAKED A SMALL AMOUNT. REPORTED TO NP, NO INTERVENTION. TUBING DISCONNECTED AND PUMP CLEANED AND RETURNED TO STORAGE.
Patient problems: Insufficient Information
MAUDE report 14429781 ↗
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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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