Shiley 8CN85EDRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521726239), received between Jan 11, 2022 and Dec 6, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, SECRETIONS WERE LEAKING FROM THE SIDE OF THE TRACHEOSTOMY TUBE HOLE THAT WAS USED PREVIOUSLY FOR THE EXTERNAL SUCTION LINE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20867901 ↗
• MalfunctionJun 17, 2024Crack; Human-Device Interface Problem; Crack; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY'S INNER CANNULA HAD CRACK THAT APPEARED AFTER BEING CLEANED BY SQUEEZING OUT THE PHLEGM STUCK DURING USE. THE INNER CANNULA WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19551158 ↗
• MalfunctionSep 12, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S PILOT BALLOON HAD A LARGE AIR LEAK DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17728953 ↗
• InjuryFeb 2, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT WAS HAVING A BEDSIDE PERCUTANEOUS TRACHEOSTOMY. THE DEVICE WAS INSERTED WITHOUT INCIDENT BUT WHEN PLACED ON THE VENTILATOR THERE WAS NO RETURN TIDAL VOLUME. THE DEVICE WAS REMOVED, AND THE CUFF FOUND TO BE DEFECTIVE. PATIENT HAD A DESATURATION OF 55% BUT RECOVERED WITH REPLACEMENT OF A NEW DEVICE.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 13434732 ↗
• MalfunctionFeb 1, 2022Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE RESPIRATORY THERAPIST WAS PAGED TO THE PATIENT AND FOUND THE CUFF ON THE PATIENT'S TUBE WAS DEFLATED AND HAD AN AUDIBLE CUFF LEAK. ATTEMPTS TO INFLATE THE BALLOON WERE UNSUCCESSFUL, WOULD QUICKLY DEFLATE. THE ORIGINAL PLACING PROVIDER TEAM NOTIFIED AND EXCHANGED FOR A SUBSTITUTE TRACH AT THE BEDSIDE. THE MD CHOSE A DIFFERENT TUBE BRAND BECAUSE THAT WAS THE SECOND TRACH CHANGE IN 24 HOURS DUE TO A CUFF LEAK. WHEN THE TUBE WAS REMOVED AND SUBMERGED IN WATER, A LEAK THROUGH A HOLE IN THE CUFF WAS NOTED.

  Patient problems: Unintended Extubation

  MAUDE report 13420095 ↗
• MalfunctionJan 31, 2022Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE RESPIRATORY THERAPIST WAS PAGED TO THE PATIENT AND FOUND THE CUFF ON THE PATIENT'S TUBE WAS DEFLATED AND HAD AN AUDIBLE CUFF LEAK. ATTEMPTS TO INFLATE THE BALLOON WERE UNSUCCESSFUL, WOULD QUICKLY DEFLATE. THE ORIGINAL PLACING PROVIDER TEAM NOTIFIED AND EXCHANGED FOR A SUBSTITUTE TRACH AT THE BEDSIDE. THE MD CHOSE A DIFFERENT TUBE BRAND BECAUSE THAT WAS THE SECOND TRACH CHANGE IN 24 HOURS DUE TO A CUFF LEAK. WHEN THE TUBE WAS REMOVED AND SUBMERGED IN WATER, A LEAK THROUGH A HOLE IN THE CUFF WAS NOTED.

  Patient problems: Unintended Extubation

  MAUDE report 13396139 ↗
• MalfunctionJan 11, 2022Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WOULD NOT REMAIN INFLATED AND FOUND A SMALL PIN HOLE ON IT. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 13225645 ↗