Shiley 86550Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521211667), received between Apr 18, 2019 and Feb 4, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING PATIENT'S SEDATION, THE ANESTHESIOLOGIST WAS UNABLE TO VISUALIZE THE ETCO2 MEASUREMENT IN THE ANESTHESIA MACHINE, AND THE EQUIPMENT'S BELLOWS WERE NOT HOLDING, INDICATING A LEAK. THE LEAK WAS DETECTED TO BE COMING FROM THE ENDOTRACHEAL TUBE BALLOON, SPECIFICALLY AT THE PILOT BALLOON SEAM. THE ENDOTRACHEAL TUBE WAS SUBSEQUENTLY CHANGED. THE EVENT TOOK PLACE IN A HOSPITAL SETTING.

  Patient problems: Unintended Extubation

  MAUDE report 21309622 ↗
• MalfunctionAug 23, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING THE PATIENT'S SEDATION, THE ANESTHESIOLOGIST WAS UNABLE TO VISUALIZE THE END-TIDAL CARBON DIOXIDE (ETCO2) MEASUREMENT ON THE ANESTHESIA MACHINE AND ALSO DETECTED THAT THE EQUIPMENT'S BELLOWS WERE NOT HOLDING, INDICATING A LEAK. AFTER CHECKING THE EQUIPMENT, IT WAS DETERMINED THAT THE LEAK ORIGINATED FROM THE ENDOTRACHEAL TUBE BALLOON, SO THE DEVICE WAS CHANGED.

  Patient problems: Unintended Extubation

  MAUDE report 20051734 ↗
• MalfunctionMar 13, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE THREE ENDOTRACHEAL TUBE'S PILOT BALLOON BLEW UP UPON CONNECTING A SYRINGE AND DEFLATES THE BALLOON AFTER REMOVING THE SYRINGE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18899546 ↗
• MalfunctionMar 13, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE THREE ENDOTRACHEAL TUBE'S PILOT BALLOON BLEW UP UPON CONNECTING A SYRINGE AND DEFLATES THE BALLOON AFTER REMOVING THE SYRINGE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18899510 ↗
• MalfunctionMar 13, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE THREE ENDOTRACHEAL TUBE'S PILOT BALLOON BLEW UP UPON CONNECTING A SYRINGE AND DEFLATES THE BALLOON AFTER REMOVING THE SYRINGE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18899499 ↗
• MalfunctionNov 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE REINFORCED TUBE'S CUFF BROKE DURING RHINOPLASTY SURGERY AND IT WAS NECESSARY TO CHANGE THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 18194925 ↗
• MalfunctionNov 22, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE REINFORCED TUBE'S CUFF BROKE DURING RHINOPLASTY SURGERY AND IT WAS NECESSARY TO CHANGE THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 18194913 ↗
• MalfunctionApr 26, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD A LEAK DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820431 ↗
• MalfunctionSep 30, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CUFF HAD AN INFLATION/DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520019 ↗
• MalfunctionNov 4, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A PHYSICAL DAMAGE WHEREIN THE CANNULA WAS DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10783814 ↗
• MalfunctionDec 30, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, WHEN INFLATING, THE DEVICE BALL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9530011 ↗
• MalfunctionJun 17, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT WAS DIFFICULT TO INFLATE AND TO DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8705376 ↗
• MalfunctionApr 18, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE PILOT BALLOON WAS INFLATED WITH SYRINGE BUT COULD NOT INFLATE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8530213 ↗