Medex MTF37Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688510327), received between May 11, 2022 and Jun 22, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Crack2
- Fluid/Blood Leak2
- Break1
- Fracture1
- Leak/Splash1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2023Break; Fluid/Blood Leak; Material Separation; Break; Fluid/Blood Leak; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE ITEM WAS BROKEN DURING PATIENT USE, BUT THE PATIENT WAS NOT HARMED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17187048 ↗MalfunctionJun 19, 2023Crack; Fluid/Blood Leak; Fracture; Crack; Fluid/Blood Leak; Fracture
IT WAS REPORTED, THAT THE DEVICE WAS LEAKING FROM THE LUER LOCK PORT, CRACKS OR SHATTERING OF THE MALE LUER LOCK CONNECTOR AT THE END. THE CRACKING OCCURED, DURING RECONNECTION AFTER A LINE DISCONNECT. VISIBLE CRACKS FOUND AFTER CONNECTING, DISCONNECTING, RECONNECTING PORT. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17157896 ↗MalfunctionMay 11, 2022Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT THE LEUR LOCK IS CRACKED AND LEAKING. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14357420 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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