Shiley 86050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884522005675), received between Mar 8, 2018 and Dec 9, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Inflation Problem” (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.

• InjuryDec 9, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF WAS PRE-TESTED WITH A SYRINGE AND IT WAS ABOUT 10CC. INTRA-OPERATIVELY, THE CUFF RUPTURED AND THE PATIENT WAS WITHOUT PROPER OXYGEN DUE TO A TEAR IN THE ENDOTRACHEAL TUBE CUFF FOR ABOUT 5-10 MINUTES DUE TO A TEAR IN THE ENDOTRACHEAL TUBE CUFF. THERE WAS A REQUIRED REPLACEMENT OF TUBE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15950171 ↗
• InjuryMar 8, 2018Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTED A DIFFICULT INTUBATION. AFTER THE PATIENT WAS INTUBATED, THE PATIENT QUICKLY DESATURATED AND AIR WAS NOTED TO BE ESCAPING AROUND TUBE. RE-INTUBATION WAS REQUIRED DUE TO DEFECTIVE ENDOTRACHEAL TUBE CUFF.

  Patient problems: Extubate

  MAUDE report 7323265 ↗

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