Mallinckrodt 110870Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521068216), received between Jun 12, 2018 and Jun 4, 2019 — classified as 8 injuries.

The most frequently reported specific device problem is “Leak/Splash” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2019Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8666618 ↗
• InjuryJun 4, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8666603 ↗
• InjuryJun 4, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8666449 ↗
• InjuryJun 3, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8664164 ↗
• InjuryJun 3, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8663832 ↗
• InjuryJun 3, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8663825 ↗
• InjuryJun 3, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8663808 ↗
• InjuryJun 12, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT WAS INTUBATED AND THE DEPTH OF THE TUBE WAS ADJUSTED. THE CUSTOMER REPORTED THAT AIR LEAK FROM THE CUFF WAS OBSERVED.

  Patient problems: Extubate

  MAUDE report 7592644 ↗

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..