Shiley 85865Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884522004091), received between Feb 22, 2021 and Oct 11, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2021Defective Device; Defective Device

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATE USING THE DEVICE WITH GUIDE TO PERFORM ARTHROSCOPY SURGERY OF THE SHOULDER UNDER GENERAL ANESTHESIA. IMMEDIATELY AFTER THE OPERATION, THE PATIENT EXPERIENCED DISCOMFORT IN THE THROAT AND WITH EPISODES OF COUGHING. THIRTEEN DAYS LATER, THE PATIENT COUGHED WITH EXPULSION OF METAL FRAGMENT OF ABOUT 2 CENTIMETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 12605975 ↗
• MalfunctionMar 18, 2021Defective Device; Defective Device

  ACCORDING TO THE REPORTER, THE GUIDE FOR THE OROTRACHEAL TUBE WAS VERY SOFT, AND AT THE TIME OF INTUBATION IT BENDED AT AN ANGLE THAT MADE IT DIFFICULT TO DIRECT THE TUBE THROUGH THE BUCCAL CORDS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11515401 ↗
• MalfunctionFeb 22, 2021Defective Device; Defective Device

  ACCORDING TO THE REPORTER, DURING INTUBATION, THE DEVICE DID NOT PROVIDE NORMAL RIGIDITY TO ETT. IT WAS INDICATED THAT THE STYLET WAS MORE MALLEABLE THAN TYPICAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358036 ↗