Mallinckrodt 86108Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 40884522000087), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

1 other recall cover devices cleared under the same FDA submission (K871204); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY,  THERE WAS A VERTICAL CRACK AT THE TIP OF THE ENDOTRACHEAL TUBE'S PILOT BALLOON AS A RESULT, AIR WAS LOST. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20043838 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K871204. One submission often covers many models, so check the product and lot details in each record.

• Z-1318-2023 · Feb 10, 2023 · Open, Classified
  COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal in