Shiley 8CN85ERRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521726307), received between Jan 31, 2022 and Jun 5, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE ON A PATIENT, THE TRACHEOSTOMY TUBE'S CUFF INTEGRITY TEST WAS PERFORMED AND FAILURE WAS OBSERVED WITH A HOLE AND LEAK IN THE CUFF. ANOTHER UNIT WAS USED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417448 ↗
• MalfunctionMar 2, 2026Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT INTRA-OPERATIVELY, EVEN THE TRACH TUBE'S CUFF WAS CHECKED BEFORE PLACEMENT, AFTER INTUBATION THE CUFF STARTED TO LOOSE PRESSURE AND FOUND RUPTURED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24484889 ↗
• MalfunctionFeb 17, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE EXPERIENCED A A LEAKING CUFF DURING USE. THE ISSUE TOOK PLACE IN A HOSPITAL SETTING. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24372889 ↗
• MalfunctionFeb 17, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE EXPERIENCED A A LEAKING CUFF DURING USE. THE ISSUE TOOK PLACE IN A HOSPITAL SETTING. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24372859 ↗
• MalfunctionApr 1, 2025Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT WITH A TRACHEOSTOMY IN PLACE EXPERIENCED ISSUES WITH A TRACHEOSTOMY TUBE. THE CUFF OF THE TRACHEOSTOMY TUBE HAD A HOLE AND DEFLATED, LEADING TO A SECOND TRACHEAL LEAK WITHIN LESS THAN 24 HOURS FOR THE SAME PATIENT. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21738585 ↗
• MalfunctionJan 3, 2025Gas/Air Leak; Human-Device Interface Problem; Gas/Air Leak; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TWO TRACHEOSTOMY TUBES DID NOT HOLD PRESSURE AND HAD BEEN CONSISTENTLY LEAKING. THE PRESSURE WAS SET AND MAINTAINED AT A PRESSURE OF 20 TO 30 CMH2O, BUT THE PRESSURE WAS DOWN TO BETWEEN 10 AND 20 WITHIN 24 HOURS, SOMETIMES LESS THAN 8 HOURS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Discomfort; Pain

  MAUDE report 21064616 ↗
• MalfunctionNov 13, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S CUFF WAS FOUND LEAKING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674803 ↗
• MalfunctionSep 10, 2024Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE COULD NOT SEAL DUE TO A LEAK AFTER ONE TO TWO DAYS OF INSERTION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179899 ↗
• MalfunctionAug 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING USE, THERE WERE TRACHEOSTOMY TUBES THAT HAD SECRETIONS LEFT IN THE SUBGLOTTIC LINES. THE REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19953570 ↗
• MalfunctionAug 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD SECRETION LEFT IN THE SUBGLOTTIC LINES. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19929239 ↗
• MalfunctionAug 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING USE, THERE WERE TRACHEOSTOMY TUBES THAT HAD SECRETION LEFT IN THE SUBGLOTTIC LINES. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19929237 ↗
• MalfunctionAug 6, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING INSPECTION, THE TRACHEOSTOMY TUBE'S CUFF WAS DEFLATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917124 ↗
• MalfunctionJun 29, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD BEEN INTUBATED FOR SEVERAL DAYS BEFORE GOING TO THE SUBGLOTTIC SECRETION UNIT. DURING THE CANNULA CHANGE, THERE WAS A SECRETION LEFT IN THE EVAC CANNULA AND SUCTION LINE AS SHOWN IN THE ATTACHED PHOTO. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19640438 ↗
• MalfunctionJun 8, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, BOTH TRACHEOSTOMY TUBES' CUFFS HAD A LEAK DURING PATIENT USAGE. THE TUBES WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19493308 ↗
• InjuryMar 15, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT DESATURATED DUE TO CUFF LEAK DURING THE PROCEDURE. THE TUBE WAS REPLACED.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 16546050 ↗
• MalfunctionJan 31, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING ROUTINE CHECK ON THE PATIENT, THE CUFF OF THE DEVICE WAS FOUND DEFLATED. ATTEMPTED TO RE-INFLATE THE CUFF BUT HAD FAILED. THE PATIENT HAD A REPLACEMENT OF THE TUBE. THE EXTUBATED DEVICE HAD CONFIRMED A LEAK ON THE CUFF.

  Patient problems: Unintended Extubation

  MAUDE report 13392598 ↗