Mallinckrodt 110875Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521068223), received between Aug 21, 2017 and Jan 28, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT'S CUFF WAS LEAKING. THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 8281780 ↗
• MalfunctionJun 13, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT OUTCOME OR INJURY.

  Patient problems: No Information

  MAUDE report 7597434 ↗
• MalfunctionAug 21, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT THERE WAS A LEAK ON THE CUFF OF ONE TUBE. THE CUSTOMER INDICATED THAT A CHANGE OF THE TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 6809187 ↗
• MalfunctionAug 21, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT THERE WAS A LEAK ON THE CUFF OF ONE TUBE. THE CUSTOMER INDICATED THAT A CHANGE OF THE TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 6809184 ↗
• MalfunctionAug 21, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT THERE WAS A LEAK ON THE CUFF OF ONE TUBE. THE CUSTOMER INDICATED THAT A CHANGE OF THE TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 6809179 ↗

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