Shiley 8CN85HRecalls & reported problems

Summary

The FDA's MAUDE database contains 354 adverse event reports that list this exact device (DI 20884521176345), received between Jan 23, 2018 and Jul 7, 2026 — classified as 2 deaths, 64 injuries, 288 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (196 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 24, 2023Open, Classified

   A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.

   Z-1357-2023 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 354 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Use of Device Problem

  IT WAS REPORTED THAT, DURING AN INTRAOPERATIVE PROCEDURE, THE BALLOON ON TWO TRACHEOSTOMY TUBES POPPED IN THE MIDDLE OF THE PROCEDURE. THE TRACHEOSTOMY TUBES WERE REPLACED FOLLOWING THE BALLOON POP. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 25732292 ↗
• MalfunctionJul 7, 2026Use of Device Problem

  IT WAS REPORTED THAT, DURING AN INTRAOPERATIVE PROCEDURE, THE BALLOON ON TWO TRACHEOSTOMY TUBES POPPED IN THE MIDDLE OF THE PROCEDURE. THE TRACHEOSTOMY TUBES WERE REPLACED FOLLOWING THE BALLOON POP. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 25732279 ↗
• MalfunctionJun 4, 2026Use of Device Problem

  IT WAS REPORTED THAT THE FOUR TRACH TUBES WERE TESTED PRIOR TO INSERTION WITH NO PROBLEMS, THEN AFTER INSERTION AND INFLATION THE BALLOON POPPED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25401931 ↗
• MalfunctionJun 4, 2026Use of Device Problem

  IT WAS REPORTED THAT THE FOUR TRACH TUBES WERE TESTED PRIOR TO INSERTION WITH NO PROBLEMS, THEN AFTER INSERTION AND INFLATION THE BALLOON POPPED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25401810 ↗
• InjuryApr 14, 2026Material Deformation

  IT WAS REPORTED THAT, DURING USE OF A TRACHEOSTOMY TUBE, IT WAS DESCRIBED AS BEING SO FLEXIBLE THAT IT KINKED, AND RESPIRATORY DISTRESS AND AN INABILITY TO VENTILATE WERE REPORTED. AN EMERGENCY ORAL INTUBATION WAS PERFORMED.

  Patient problems: Respiratory Insufficiency; Unintended Extubation

  MAUDE report 24879321 ↗
• InjuryApr 1, 2026Material Deformation

  IT WAS REPORTED THAT, DURING USE OF A TRACHEOSTOMY TUBE, IT WAS DESCRIBED AS BEING SO FLEXIBLE THAT IT KINKED, AND RESPIRATORY DISTRESS AND AN INABILITY TO VENTILATE WERE REPORTED. AN EMERGENCY ORAL INTUBATION WAS PERFORMED.

  Patient problems: Respiratory Insufficiency; Unintended Extubation

  MAUDE report 24757690 ↗
• MalfunctionJan 21, 2026Use of Device Problem

  IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, TRACHEOSTOMY TUBES WERE OPENED AND CUFFS WOULD NOT INFLATE. IT WAS NECESSARY TO SWITCH TO SIZE 7.5 DUE TO ALL DEVICES OF THE ORIGINAL SIZE FAILING, WITH TWO DEVICES FROM THE SAME LOT AFFECTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141159 ↗
• MalfunctionJan 21, 2026Use of Device Problem

  IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, TRACHEOSTOMY TUBES WERE OPENED AND CUFFS WOULD NOT INFLATE. IT WAS NECESSARY TO SWITCH TO SIZE 7.5 DUE TO ALL DEVICES OF THE ORIGINAL SIZE FAILING, WITH TWO DEVICES FROM THE SAME LOT AFFECTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141139 ↗
• MalfunctionOct 20, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE BALLOON OF THE TRACHEOSTOMY TUBE POPPED DURING INSERTION INTO PATIENT. NO PATIENT COMPLICATIONS OR HARMS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344245 ↗
• MalfunctionOct 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USAGE, THE TRACH TUBE'S CUFF HAD ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335628 ↗
• MalfunctionOct 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USAGE, THE TRACH TUBE'S CUFF HAD ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335536 ↗
• MalfunctionOct 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USAGE, THE TRACH TUBE'S CUFF HAD ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335521 ↗
• MalfunctionOct 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE BALLOON OF THE TRACHEOSTOMY TUBE POPPED DURING INSERTION INTO PATIENT. NO PATIENT COMPLICATIONS OR HARMS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318893 ↗
• InjuryAug 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOW EXHALED TIDAL VOLUME (VTE) ON THE VENTILATOR DUE TO AN AIR LEAK AROUND THE STOMA, CAUSING INADEQUATE VENTILATION. THE PILOT BALLOON WAS MOSTLY DEFLATED, WITH SIZE FLUCTUATIONS CORRESPONDING TO PATIENT RESPIRATIONS. MINIMAL LEAK TECHNIQUE (MLT) WAS PERFORMED, BUT THE CUFF FAILED TO HOLD PRESSURE. AN EMERGENCY TRACHEOSTOMY TUBE CHANGE WAS PERFORMED. POST-PROCEDURE TESTING OF THE TUBE VIA A WATER AIR LEAK TEST CONFIRMED A BLOWN CUFF.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 22913077 ↗
• MalfunctionAug 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE THREE TRACHEOSTOMY TUBES WAS NOT HOLDING AIR SHORTLY AFTER BEING PLACED. REPLACEMENT OF THE TUBE WAS DONE THREE TIMES.

  Patient problems: Unintended Extubation

  MAUDE report 22846514 ↗
• MalfunctionAug 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE THREE TRACHEOSTOMY TUBES WAS NOT HOLDING AIR SHORTLY AFTER BEING PLACED. REPLACEMENT OF THE TUBE WAS DONE THREE TIMES.

  Patient problems: Unintended Extubation

  MAUDE report 22846497 ↗
• MalfunctionAug 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE THREE TRACHEOSTOMY TUBES WAS NOT HOLDING AIR SHORTLY AFTER BEING PLACED. REPLACEMENT OF THE TUBE WAS DONE THREE TIMES.

  Patient problems: Unintended Extubation

  MAUDE report 22846488 ↗
• InjuryAug 19, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS NOTED WITH LOW EXHALED TIDAL VOLUME (VTE) ON VENTILATOR FOR A MINUTE WITH AIR LEAK AROUND STOMA RESULTING IN INADEQUATE VENTILATION. THE PILOT BALLOON WAS MOSTLY DEFLATED, WITH FLUCTUATIONS IN SIZE CORRESPONDING TO PATIENT RESPIRATIONS. MINIMAL LEAK TECHNIQUE (MLT) WAS PERFORMED AND THE CUFF WOULD NOT HOLD PRESSURE. AN EMERGENCY TRACHEOSTOMY CHANGE WAS PERFORMED. POST-PROCEDURE, A WATER AIR LEAK TEST CONFIRMED A "RUPTURED" CUFF.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 22838475 ↗
• MalfunctionAug 18, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE TWO TRACHEOSTOMY TUBE HAD NOT HOLDING AIR SHORTLY AFTER BEING PLACED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22836005 ↗
• MalfunctionAug 5, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE; THE TRACH TUBE'S CUFF HAD AN AIR LEAK AFTER 5-10 MINUTES OF PATIENT INSERTION. THE TUBE WAS IMMEDIATELY REPLACED WITH NO ADVERSE EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 22718933 ↗
• MalfunctionJun 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WERE SEVERE CUFF INFLATION ISSUES WITH BOTH TRACH TUBES OBSERVED PRE-OPERATIVELY WHILE PREPARING FOR USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179827 ↗
• MalfunctionMay 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WERE SEVERE CUFF INFLATION ISSUES WITH BOTH TRACH TUBES OBSERVED PRE-OPERATIVELY WHILE PREPARING FOR USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115395 ↗
• MalfunctionMay 22, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S BALLOON WAS NOT HOLDING AIR. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22071760 ↗
• MalfunctionApr 28, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING PATIENT USE, THREE TRACH TUBE'S CUFF DEFLATED AND UNABLE TO RE-INFLATE. THE TUBES WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21920572 ↗
• MalfunctionApr 28, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING PATIENT USE, THREE TRACH TUBE'S CUFF DEFLATED AND UNABLE TO RE-INFLATE. THE TUBES WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21920412 ↗