Mallinckrodt 86462Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 60884522005468), received between Sep 14, 2018 and Sep 14, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Connection 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 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.

• InjurySep 14, 2018Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE UNIT UNIT'S ADAPTOR WAS BROKEN. IT WAS REPORTED THAT WHEN REMOVING IT TO GIVE SURFACTANT, THE ADAPTOR SNAPPED. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 7876869 ↗
• InjurySep 14, 2018Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE UNIT UNIT'S ADAPTOR WAS BROKEN. IT WAS REPORTED THAT WHEN REMOVING IT TO GIVE SURFACTANT, THE ADAPTOR SNAPPED. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 7876835 ↗