Medex MX451FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10351688507310), received between May 27, 2021 and May 26, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT FOUR REPORTS FOR TUBING DISCONNECTION. PATIENT WAS RECEIVING CRYO AND INTRAVENOUS (IV) TUBING CAME APART. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 10 SEPT 2021 - MEDWATCH ATTACHMENT NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009302 ↗
• MalfunctionFeb 14, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE EXTENSION TUBING USED THAT GOES AT THE END OF THE TPN AND LIPID SET UP, SNAPPED OFF FROM PICC CAP. THE CONNECTING PIECE ON THE TUBING WAS STILL ATTACHED TO THE PICC CAP, AND THE TUBING ITSELF BECAME DETACHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13527458 ↗
• MalfunctionMay 27, 2021Disconnection; Disconnection

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET CAME APART AT THE DISTAL PORTION SUDDENLY AND BLOOD WAS FLOWING EVERYWHERE. THEN PATIENT BLEEDING EVERYWHERE DUE TO THE DISCONNECTION OF THE DISTAL PART OF THE TUBING. THERE WERE NO OTHER ADVERSE EVENTS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896122 ↗
• InjuryMay 27, 2021Disconnection; Disconnection

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET CAME APART AT THE DISTAL PORTION SUDDENLY AND BLOOD WAS FLOWING EVERYWHERE. THEN PATIENT BLEEDING EVERYWHERE DUE TO THE DISCONNECTION OF THE DISTAL PART OF THE TUBING. THERE WERE NO OTHER ADVERSE EVENTS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11896045 ↗
• InjuryMay 27, 2021Disconnection; Disconnection

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET CAME APART AT THE DISTAL PORTION SUDDENLY AND BLOOD WAS FLOWING EVERYWHERE. THEN PATIENT BLEEDING EVERYWHERE DUE TO THE DISCONNECTION OF THE DISTAL PART OF THE TUBING. THERE WERE NO OTHER ADVERSE EVENTS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11895943 ↗