Medex MX448HLRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688507440), received between Oct 13, 2022 and Oct 13, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 13, 2022Defective Device; Defective Device
IT WAS REPORTED THAT FLUID WOULD NOT FLOW THROUGH TUBING WHEN ADMINISTERING FLUID OR MEDICATION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15595390 ↗
Other Tubing, fluid delivery devices
- High Pressure Tubing CMerit Medical Systems, Inc. · Tubing, fluid delivery1 recall0 reports
- High Pressure Tubing CMerit Medical Systems, Inc. · Tubing, fluid delivery1 recall0 reports
- Medex MX43660Icu Medical, Inc. · Tubing, fluid delivery27 reports
- Medex MX43860Icu Medical, Inc. · Tubing, fluid delivery13 reports
- Medex MX451FLIcu Medical, Inc. · Tubing, fluid delivery5 reports
- Medex MX452FLIcu Medical, Inc. · Tubing, fluid delivery5 reports
- 10 in. (25 cm) Q2 Checkmate extension set 9545Quest Medical Inc · Tubing, Fluid Delivery3 reports
- Medex MX450FLIcu Medical, Inc. · Tubing, fluid delivery3 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page