Medex MX560Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10351688506597), received between Dec 21, 2020 and Apr 9, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Backflow1
- Fluid/Blood Leak1
- Leak/Splash1
- Material Separation1
Patient problems
- Bradycardia2
- High Blood Pressure/ Hypertension2
- Insufficient Information1
- 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.
MalfunctionApr 9, 2026Leak/Splash
IT WAS STATED THAT THE IV EXTENSION PIECE CRACKED, AND BLOOD BACKED UP IN THE LINE. PATIENT WAS AFFECTED. THE LINE HAD BEEN RUNNING TPN AND LIPIDS FOR ABOUT 12 HOURS BEFORE IT CRACKED. THERE WAS NO HARM TO THE PATIENT, AND THEY CONTACTED THE RESPONSIBLE PERSON. NO MONITORING WAS REQUIRED. THE EVENT WAS RESOLVED. THE PATIENT WAS A 5-MONTH-OLD WHITE/CAUCASIAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830336 ↗MalfunctionNov 6, 2023Backflow; Fluid/Blood Leak; Material Separation; Backflow; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT THE REGISTERED NURSE NOTICED THAT BLOOD WAS BACKING UP IN CATHETER TUBING. IT WAS THEN NOTICED THAT BLOOD WAS DRIPPING FROM THE TUBING. WHILE DOING THE ALCOHOL SCRUB, THE TUBING FELL APART ("BROKE IN AT END, NEAR CONNECTION"). ADVERSE EFFECTS HAVE NOT BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 18075113 ↗InjuryDec 21, 2020Break; Break
ADDITIONAL INFORMATION WAS PROVIDED DETAILING THAT NO ACLS MEDS WERE GIVEN. THE PATIENT'S VITALS NORMALIZED AFTER ECMO FLOWS WERE RESTORED.
Patient problems: Bradycardia; High Blood Pressure/ Hypertension
MAUDE report 11052031 ↗InjuryDec 21, 2020Break; Break
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TUBING PIGTAIL BROKE OFF AT THE CRRT ACCESS SITE (PRE STOPCOCK) WHILE HOISTING THE PATIENT UP IN THE BED. THERE WAS NO NOTICED STRETCHING OF THE PLASTIC TO MAKE THE TUBING BREAK. THE PIGTAIL WAS SHOOTING BLOOD OUT OF THE ECMO CIRCUIT ONTO THE BED AND FLOOR. IT WAS CLAMPED OFF TO STOP BLEEDING. A NEW PIGTAIL AND STOPCOCK WERE PRIMED TO RESOLVE THE EVENTS. PATIENT WAS CLAMPED OFF ECMO FOR 20 SECONDS WHILE A NEW PIGTAIL WAS PLACED. PATIENT BECAME BRADYCARDIC INTO THE 30'S, AND HYPERTENSIVE. THERE WERE NO OTHER ADVERSE EVENTS REPORTED.
Patient problems: Bradycardia; High Blood Pressure/ Hypertension
MAUDE report 11049782 ↗
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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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