Mallinckrodt 86450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 60884522000463), received between Oct 11, 2019 and Oct 14, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, TWO DEVICES POPPED DURING THE CASE. IT WAS REPORTED THAT RE-INTUBATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 9184109 ↗
• InjuryOct 11, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, TWO DEVICES POPPED DURING THE CASE. IT WAS REPORTED THAT WERE TWO REINTUBATIONS REQUIRED.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 9178078 ↗