Medex MX448F78MGRecalls & 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10351688518842), received between Jun 17, 2021 and May 4, 2022 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 Leak6
- Obstruction of Flow2
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT TWO SETS OF MAGNUM TUBING WOULD NOT ALLOW WITHDRAW OF FLUID FROM IV BAG WHEN SPIKED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14279393 ↗MalfunctionMay 4, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT TWO SETS OF MAGNUM TUBING WOULD NOT ALLOW WITHDRAW OF FLUID FROM IV BAG WHEN SPIKED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14279313 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET WAS LEAKING DURING USE WITH IV FLUID WITH NICU PATIENTS. THERE WERE NO REPORTED ADVERSE EVENTS.
Patient problems: Insufficient Information
MAUDE report 12020902 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET WAS LEAKING DURING USE WITH IV FLUID WITH NICU PATIENTS. THERE WERE NO REPORTED ADVERSE EVENTS.
Patient problems: Insufficient Information
MAUDE report 12020887 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET WAS LEAKING DURING USE WITH IV FLUID WITH NICU PATIENTS. THERE WERE NO REPORTED ADVERSE EVENTS.
Patient problems: Insufficient Information
MAUDE report 12020839 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET WAS LEAKING DURING USE WITH IV FLUID WITH NICU PATIENTS. THERE WERE NO REPORTED ADVERSE EVENTS.
Patient problems: Insufficient Information
MAUDE report 12020803 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET WAS LEAKING DURING USE WITH IV FLUID WITH NICU PATIENTS. THERE WERE NO REPORTED ADVERSE EVENTS.
Patient problems: Insufficient Information
MAUDE report 12020678 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET WAS LEAKING DURING USE WITH IV FLUID WITH NICU PATIENTS. THERE WERE NO REPORTED ADVERSE EVENTS.
Patient problems: Insufficient Information
MAUDE report 12019650 ↗
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- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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