Mallinckrodt 18865Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30884521032518), received between Aug 18, 2017 and Sep 24, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inflation 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 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.

• MalfunctionSep 24, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER INTUBATION, 7CC OF AIR WAS INJECTED INTO THE CUFF. WHEN THE TUBE WAS FOR EXTUBATING, THE AIR WAS SUCTIONED, DENT OF THE PILOT BALLOON WAS CHECKED BUT THE REMAINING AIR IN THE CUFF WAS FOUND. THE PILOT BALLOON, CUFF AND INFLATION LINE WERE FOR INSPECTION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525558 ↗
• InjuryAug 18, 2017Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER RIGHT AFTER THE PATIENT WAS INTUBATED, IT WAS DIFFICULT TO SUPPLY AIR TO THE CUFF. IT WAS REPORTED, POST PROCEDURE THE CUFF WAS NOT DEFLATED COMPLETELY BUT REMOVED FROM THE PATIENT. CUSTOMER COULD NOT CONFIRM IF ISSUE WAS FOUND DURING PRE-TEST. THERE WAS NO PATIENT HARM WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6804709 ↗