Medex MX458LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688507075), received between Jun 22, 2021 and Mar 29, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SIX (6) INCH Y EXTENSION WAS LEAKING WHILE IN USE WITH PATIENT. NO INJURY AND NO MEDICAL INTERVENTION WAS REPORTED. THE LINES WERE RE-PRIMED, AND EXTENSIONS WERE REPLACED. THE EXTENSION SET WAS ALSO NOTED TO BE CRACKED IN SUBSEQUENT NIGHTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639594 ↗
• MalfunctionMar 29, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SIX (6) INCH Y EXTENSION WAS LEAKING WHILE IN USE WITH PATIENT. NO INJURY AND NO MEDICAL INTERVENTION WAS REPORTED. THE LINES WERE REPRIMED, AND EXTENSIONS WERE REPLACED. THE EXTENSION SET WAS ALSO NOTED TO BE CRACKED IN SUBSEQUENT NIGHTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639553 ↗
• InjuryJun 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET WAS FLUSHED AND A LEAK WAS NOTED FROM TRIFUSE IV EXTENSION TUBING (PRODUCT NEW FROM PACKAGING, WITHIN 30 MINS OF EVENT). THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12043140 ↗