Mallinckrodt 110880Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521068230), received between Feb 28, 2019 and Sep 15, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K082520); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, APPROXIMATELY 5CC OF WATER DROPLETS ACCUMULATED IN THE CUFF OF THE TUBE DURING USE. THE TUBE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 20221231 ↗
• MalfunctionMay 4, 2021Fluid/Blood Leak; Use of Device Problem; Fluid/Blood Leak; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER COLLECTED IN PILOT BALLOON. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769539 ↗
• InjuryMay 14, 2019Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  ACCORDING TO THE REPORTER, WHILE INSERTED TO A PATIENT, THE UNIT'S CUFF PRESSURE DECREASED. THEREFORE, AIRFLOW WAS PERFORMED BUT THE CUFF PRESSURE DID NOT INCREASE AND AIR LEAK SOUND WAS HEARD DURING PATIENT BREATHING. REPLACEMENT OF TUBE WAS DONE, THUS THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 8608402 ↗
• InjuryFeb 28, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, ABOUT 5 DAYS AFTER INTUBATION, A LOT OF FLUID (BEYOND THE AMOUNT OF DEW CONDENSATION) WAS FOUND INSIDE THE PILOT BALLOON. AFTER EXTUBATION, THE FLUID WAS ALSO FOUND INSIDE THE CUFF. DURING RE-INTUBATION, AUTO CUFF PRESSURE CONTROLLER WAS USED TO MANAGE THE CUFF PRESSURE. AT THIS TIME, THE CUFF PRESSURE WAS MANAGED, BUT IN THE PAST, IT BECAME DIFFICULT TO MANAGE THE CUFF PRESSURE DUE TO THE SAME FLUID ISSUE, AND THE EVENTS OF THE UPPER RESPIRATORY TRACT AIR LEAKAGE OR THE VOICE LEAKAGE OCCURRED.

  Patient problems: Extubate

  MAUDE report 8377582 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082520. One submission often covers many models, so check the product and lot details in each record.

• Z-1625-2016 · Apr 4, 2016 · Terminated
  Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
• Z-1626-2016 · Apr 4, 2016 · Terminated
  Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..