Shiley 86054Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 40884522043800), received between Dec 4, 2023 and Jun 19, 2025 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT CUFF OF THE ENDOTRACHEAL TUBE HAD INFLATION AND DEFLATION ISSUES DURING USE IN A HOSPITAL SETTING. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22294518 ↗
• DeathDec 12, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT ARRIVED WITH LARYNGEAL MASK AIRWAYS (LMA) AND WAS INTUBATED IN THE ICU. THE PATIENT WAS INTUBATED, AND A LEAK AROUND THE ENDOTRACHEAL WAS OBSERVED. INITIALLY, THE LEAK WAS SMALL, AND THE PATIENT'S OXYGENATION WAS MAINTAINED. THE LEAK INCREASED, CAUSING THE NEED FOR A REPLACEMENT TUBE. DUE TO THE PATIENT'S SEVERE RESPIRATORY COMPROMISE, DURING REPLACEMENT, THE PATIENT DESATURATED. DESPITE CONTINUOUS INTERVENTION, THE PATIENT LATER CODED AND EXPIRED. THE DOCTOR SAID THAT WHEN THE TUBE WAS PULLED, IT WAS NOT TAUT, BUT IT DID NOT APPEAR TO HAVE A HOLE. THE TUBE WAS SAVED, AND THE NURSES FILLED IT WITH BETADINE TO LOOK FOR LEAKS. NO LEAKS HAVE BEEN FOUND.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 18315549 ↗
• MalfunctionDec 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THERE WAS A LEAK AROUND THE ENDOTRACHEAL TUBE. WITH ADJUSTMENT, IT WAS ABLE TO SEAL. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18306835 ↗
• MalfunctionDec 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THERE WAS A LEAK AROUND THE ENDOTRACHEAL TUBE. IT WAS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18298415 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PATIENT ARRIVED IN THE EMERGENCY DEPARTMENT WITH A LEAK, AND THE BALLOON OF THE ENDOTRACHEAL TUBE DID NOT HOLD AIR. THE TUBE WAS REPLACED, AND A HOLE WAS FOUND IN THE BALLOON. THE TUBE WAS REPLACED WITH NO FURTHER LEAKAGE.

  Patient problems: Unintended Extubation

  MAUDE report 18263439 ↗

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