Medex MX413SLRecalls & 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 10351688507822), received between Jul 12, 2023 and Mar 2, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Break1
- Crack1
- Degraded1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026
J LOOP CATHETER BROKE OFF FROM END CAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24477524 ↗MalfunctionNov 12, 2024Degraded; Fluid/Blood Leak; Fracture; Degraded; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT THE IV WAS LEAKING WHERE THE EXTENSION TUBING CONNECTS TO THE MICROCLAVE. UPON INVESTIGATION, IT WAS NOTED THAT THE MALE PORTION OF THE EXTENSION TUBING HAD BEEN DEGRADED AND CRACKED WHICH RESULTED IN THE LEAK. THE EXTENSION TUBING WAS REPLACED, AND NO FURTHER LEAKS WERE NOTED. THERE WAS A PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20664958 ↗MalfunctionNov 12, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT IV EXTENSION TUBING MALE END BROKE OFF INTO MICROCLAVE CAP WHEN DISCONNECTING IV TUBING. WHEN THE TUBING WAS DISCONNECTED, IT DID NOT SEEM STUCK, BUT WHEN IT WAS TWISTED AND DISCONNECTED THE LINE, THE PIECE HAD BROKEN BECAUSE BLOOD WAS BACKING UP AND DRIPPING OUT OF THE CAP. THERE WAS A PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20664246 ↗MalfunctionJul 12, 2023Crack; Crack
IT WAS REPORTED THAT THERE WAS A CRACK AND BREAKAGE NOTED AT THE MALE END OF THE TUBING. PATIENT INVOLVEMENT IS UNKNOWN. ADVERSE EFFECTS HAVE NOT BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 17307686 ↗
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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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