Mallinckrodt 86550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884522043359), received between Jan 11, 2018 and Sep 18, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 18, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY MATERIAL, SHORTER IN LENGTH, AND WAS EASILY KINKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886439 ↗
• MalfunctionJan 11, 2018Inflation Problem; Inflation Problem

  ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE TUBE WAS REPLACED WITH ANOTHER OF THE SAME REFERENCE.

  Patient problems: Extubate; No Known Impact Or Consequence To Patient

  MAUDE report 7184776 ↗