Shiley 86398Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884522002066), received between Mar 14, 2019 and Mar 9, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S OUTER EDGE BETWEEN THE BALLOON AND THE TUBE HAD AN AIR BUBBLE COMING OUT AS A SIGN OF LEAK. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 13711634 ↗
• MalfunctionAug 12, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD A LEAK AT THE ATTACHMENT OF THE DISTAL TUBE INTO THE LASER TUBES -- A BREAK IN THE INTEGRITY OF THE TUBE ITSELF. THERE WAS NO PATIENT INJURY/HARM.

  Patient problems: Insufficient Information

  MAUDE report 12312472 ↗
• MalfunctionMay 21, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD LEAKED.

  Patient problems: No Information

  MAUDE report 8629296 ↗
• MalfunctionMay 8, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD LEAKED PILOT BALLOON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8593080 ↗
• InjuryMar 14, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TIP OF THE TUBE WAS NOT CORRECTLY IDENTIFIED DUE TO ITS IMAGE ON X-RAY AND THE WAY IT WAS PROJECTED ON THE X-RAY GAVE A FALSE IMPRESSION OF THE TIP. IT WAS STATED THAT IT RESULTED IN RIGHT MAINSTREAM INTUBATION, LEFT LUNG COLLAPSE, HYPOXIA, ARTERIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND KIDNEY FAILURE. THE PATIENT REMAINS INTUBATED WITH THE DEVICE.

  Patient problems: Extubate; Injury

  MAUDE report 8422646 ↗