Shiley 86209Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884522006415), received between Nov 20, 2023 and May 19, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Disconnection” (8 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE EIGHT TRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045639 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE EIGHT TRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045588 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE EIGHT TRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045570 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE EIGHT TRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045556 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE EIGHT TRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045537 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE EIGHT TRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045521 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE EIGHT TRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045072 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE EIGHT TRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE..THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045035 ↗
• MalfunctionFeb 13, 2024Human-Device Interface Problem; Material Split, Cut or Torn; Human-Device Interface Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE "CRUSHED" UNDER THE RETRACTION DURING THE PROCEDURE, AND WAS UNABLE TO VENTILATE. IT WAS MORE DIFFICULT TO THE SURGEON TO PERFORM THE SURGERY AND USE THE RETRACTOR. THE TUBE WAS REPLACED.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 18700108 ↗
• MalfunctionFeb 13, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE "CRUSHED" UNDER THE RETRACTION DURING THE PROCEDURE, AND WAS UNABLE TO VENTILATE. IT WAS MORE DIFFICULT TO THE SURGEON TO PERFORM THE SURGERY AND USE THE RETRACTOR.

  Patient problems: Hypoventilation

  MAUDE report 18699971 ↗
• MalfunctionJan 9, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE KINKS WHEN IN USE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18472992 ↗
• MalfunctionNov 20, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF WOULD NOT STAY DEFLATED NOR INFLATED INDICATING CUFF MALFUNCTION OR LEAK WHEN TESTED. THIS HAPPENED TO THREE OUT OF FIVE TUBES TODAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174874 ↗
• MalfunctionNov 20, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF WOULD NOT STAY DEFLATED NOR INFLATED INDICATING CUFF MALFUNCTION OR LEAK WHEN TESTED. THIS HAPPENED TO THREE OUT OF FIVE TUBES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173807 ↗
• MalfunctionNov 20, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF WOULD NOT STAY DEFLATED NOR INFLATED INDICATING CUFF MALFUNCTION OR LEAK WHEN TESTED. THIS HAPPENED TO THREE OUT OF FIVE TUBES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173774 ↗