Mallinckrodt 86224Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50884522005775), received between May 23, 2019 and Sep 2, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS A STICKY RESIDUE FOUND AT THE END OF THE TUBES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953201 ↗
• MalfunctionMay 23, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCORDING TO THE REPORTER, AT THE TIME OF DELIVERY OF THE INPUT, THE DEVICE WAS SEPARATED FROM THE ADAPTER WHICH MAKES IT NO LONGER WORK. THE FAILURE WAS NOTED BEFORE IT WAS USED IN PATIENT AND IT WAS NOT USED IN A PATIENT. THE ISSUE WAS HAPPENED DURING DISPENSATION FROM PHARMACY, THUS THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8638648 ↗