Mallinckrodt 5-18541Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521105574), received between Jun 21, 2021 and Jun 21, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY, A SYSTEMATICALLY REVIEWED POSTMORTEM CT WAS TO IDENTIFY AND CLASSIFY EXTRAGLOTTIC AIRWAY DEVICE MISPLACEMENT. THE CLASSIFICATION SYSTEM CONSISTED OF 6 COMPONENTS: DEPTH, SIZE, ROTATION, DEVICE KINKING, MECHANICAL BLOCKAGE OF VENTILATION OPENING, AND INJURY. THE RETROGLOTTIC AIRWAY DEVICES HAD 2 BALLOONS, ONE SEALING OFF THE PHARYNX AND THE OTHER SEALING OFF THE ESOPHAGUS, WITH VENTILATION INTO THE AIRWAY OCCURRING FROM HOLES BETWEEN THE 2 BALLOONS, WHILE THE ESOPHAGEAL-TRACHEAL COMBITUBE DIFFERED FROM OTHER RETROGLOTTIC AIRWAY DEVICES AS IT HAD DUAL LUMENS AND PROVIDE VENTILATION WHETHER THE DEVICE SITS IN THE ESOPHAGUS OR TRACHEA. UNDER THE SYSTEM, EXTRAGLOTTIC AIRWAY DEVICES WERE FOUND TO BE MISPLACED IN 49 CASES (14.4%), INCLUDING 5 (1.5%) THAT RESULTED IN SEVERE INJURIES.

  Patient problems: Airway Obstruction

  MAUDE report 12032484 ↗