Shiley 96365Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 40884521157454), received between Jan 18, 2018 and Feb 26, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE USED TO REPLACE THE PREVIOUS ONE, HAD CUFF INFLATION OR DEFLATION.AS WELL. A TUBE FROM ANOTHER BRAND WAS USED.

  Patient problems: Unintended Extubation

  MAUDE report 21471703 ↗
• MalfunctionFeb 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE USED TO REPLACE THE PREVIOUS ONE, HAD CUFF INFLATION OR DEFLATION.AS WELL. A TUBE FROM ANOTHER BRAND WAS USED.

  Patient problems: Unintended Extubation

  MAUDE report 21465607 ↗
• MalfunctionJun 21, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S BALLOON DID NOT INFLATE BEFORE USE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19590289 ↗
• MalfunctionNov 13, 2023Disconnection; Labelling, Instructions for Use or Training Problem; Disconnection; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE CONNECTOR WAS SEPARATED FROM THE ENDOTRACHEAL TUBE. IT WAS ALSO REPORTED THAT THERE WAS A LABELING ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18124474 ↗
• MalfunctionOct 19, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, UPON ATTEMPTING TO INFLATE THE CUFF OF THE ENDOTRACHEAL TUBE, THE SYRINGE PLUNGER WAS UNABLE TO DEPRESS DESPITE THE HIGH PRESSURE. IT WAS UNCLEAR AT THE TIME IF THE ISSUE WAS WITH PATIENT OR EQUIPMENT. THE NASAL TUBE WAS REMOVED, AND THE PATIENT WAS VENTILATED AND REINTUBATED WITH AN ORAL ENDOTRACHEAL TUBE. UPON FURTHER INVESTIGATION OF THE NASAL TUBE, THE PILOT BALLOON LINE HAS WHAT APPEARS TO BE A MANUFACTURING DEFECT JUST AT THE POINT THE LINE EXITS THE BODY OF THE ENDOTRACHEAL TUBE THAT CAUSED THE LINE TO KINK UNLESS GENTLE TRACTION WAS HELD ON THE LINE. DUE TO THE DEFECT, THE PATIENT UNDERWENT ADDITIONAL LARYNGOSCOPY, AND THE ENDOTRACHEAL TUBE WAS NOT THE IDEAL ONE FOR THE DESIRED SURGICAL EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 17968088 ↗
• MalfunctionJan 6, 2022Defective Component; Human-Device Interface Problem; Defective Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CANNULA WAS TOO RIGID. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175767 ↗
• MalfunctionAug 10, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD INFLATION/DEFLATION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304862 ↗
• MalfunctionJan 18, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS LOSING AIR. NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Patient Involvement

  MAUDE report 7203725 ↗