Shiley 86109Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884522000093), received between Jul 13, 2020 and Mar 11, 2026 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE USE OF AN ENDOTRACHEAL TUBE, THE BALLOON HAD A HOLE THAT PREVENTED THE TUBE FROM BECOMING SECURED. AS A RESULT, THE TUBE HAD TO BE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24576332 ↗
• InjuryJul 13, 2020Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE FOR A CESAREAN SECTION, THE PATIENT WAS NOT GETTING VOLUMES BECAUSE THE DEVICE CUFF WAS LEAKING. THE PATIENT WAS EXTUBATED AND IT WAS FOUND OUT WHEN THE CUFF WAS REMOVED THAT IT WAS RIPPED.

  Patient problems: Extubate

  MAUDE report 10268382 ↗

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