Shiley 8CN85RRecalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10884521205451), received between Jan 23, 2019 and Sep 17, 2026 — classified as 13 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (39 reports).

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

1 other recall cover devices cleared under the same FDA submission (K150844); they may or may not involve this specific model.

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 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812150 ↗
• MalfunctionSep 17, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811751 ↗
• MalfunctionJul 30, 2026Use of Device Problem; Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 50090258 ↗
• MalfunctionJul 28, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059739 ↗
• MalfunctionJun 29, 2026Gas/Air Leak

  IT WAS REPORTED THAT PRIOR TO USE, THE BALLOON OF THE TRACHEOSTOMY TUBE HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651695 ↗
• MalfunctionJun 25, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TRACH TUBE HAD DIMENSIONAL ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627000 ↗
• MalfunctionApr 17, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TRACH TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910442 ↗
• MalfunctionApr 15, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TRACH TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884316 ↗
• MalfunctionJan 28, 2026Use of Device Problem

  IT WAS REPORTED THAT AT THE HOSPITAL, THE TRACHEOSTOMY TUBE EXPERIENCED ISSUES WITH THE PILOT BALLOON PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206275 ↗
• MalfunctionJan 28, 2026Use of Device Problem

  IT WAS REPORTED THAT AT THE HOSPITAL, THE TRACHEOSTOMY TUBE EXPERIENCED ISSUES WITH THE PILOT BALLOON PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206264 ↗
• MalfunctionDec 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE FIRST INSTALLATION OF THE TRACHEOSTOMY TUBE, THE HEALTHCARE PROFESSIONAL NOTICED THAT THE CUFF WAS LOSING PRESSURE AND DECIDED TO REPLACE THE CANNULA. HOWEVER, THE ISSUE RECURRED AFTER REPLACEMENT. THE TUBE WAS THEN REPLACED BY A DIFFERENT BRAND AND SMALLER SIZE.

  Patient problems: Unintended Extubation

  MAUDE report 23855378 ↗
• MalfunctionDec 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE FIRST INSTALLATION OF THE TRACHEOSTOMY TUBE, THE HEALTHCARE PROFESSIONAL NOTICED THAT THE CUFF WAS LOSING PRESSURE AND DECIDED TO REPLACE THE CANNULA. HOWEVER, THE ISSUE RECURRED AFTER REPLACEMENT. THE TUBE WAS THEN REPLACED BY A DIFFERENT BRAND AND SMALLER SIZE.

  Patient problems: Unintended Extubation

  MAUDE report 23855374 ↗
• MalfunctionDec 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN AIR LEAKAGE OCCURRED IN THE CUFF OF THE TRACHEOSTOMY TUBE PRIOR TO USE, AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735044 ↗
• MalfunctionNov 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY CANNULA'S CUFF "BURST" WHICH MADE IT IMPOSSIBLE TO USE ON THE PATIENT. IT WAS NECESSARY TO REMOVE THE DEFECTIVE CANNULA AND REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 23452210 ↗
• MalfunctionOct 21, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DUE TO THE PATIENT'S CONDITION, A TRACHEOTOMY WAS PERFORMED AND THE PROCEDURE WENT SMOOTHLY. AN HOUR AFTER THE SURGERY, A CUFF "RUPTURE" WAS DISCOVERED. THE TRACHEOSTOMY TUBE WAS REPLACED, THE AIR LEAK NO LONGER OCCURRED, AND THE PATIENT'S CONDITION WAS NOT AFFECTED.

  Patient problems: Unintended Extubation

  MAUDE report 23351314 ↗
• MalfunctionJun 30, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE 8.0MM TRACHEOSTOMY TUBE WAS LEAKING AIR RAPIDLY AFTER 1 DAY OF PATIENT USE IN A HOSPITAL SETTING. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22366766 ↗
• InjuryJun 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AT A HOSPITAL, THE 8.5MM AND 7.0MM TRACHEOSTOMY TUBES HAD A LEAKING CUFF DURING THE PROCEDURE BASED ON THE VIDEO PROVIDED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 22231039 ↗
• MalfunctionJun 16, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE LOSS OF PRESSURE DURING USE AND HAD ISSUE WITH THE PILOT BALLOON. THE TUBE WAS ALREADY REMOVED FROM THE PATIENT BASED ON THE ATTACHED PHOTO. REPLACEMENT OF THE TUBE AS DONE AND A NEW CANNULA WAS GIVEN.

  Patient problems: Unintended Extubation

  MAUDE report 22216407 ↗
• MalfunctionJun 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE 8.5 MM TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE OR DEFLATE DURING USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179872 ↗
• MalfunctionMar 21, 2025Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  IT WAS REPORTED THAT THE 8.5 MM TRACHEOSTOMY TUBE EXPERIENCED ISSUES WITH CUFF AS IT FAILED TO SEAL WHEN INFLATED DURING MECHANICAL VENTILATION AT A HOSPITAL. THE CANNULA WAS REPLACED AND FOUND THAT THE CUFF HAD A BREAKAGE.

  Patient problems: Unintended Extubation

  MAUDE report 21670990 ↗
• MalfunctionMar 20, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A CUFF INFLATION/DEFLATION ISSUE WITH THE 8.5MM TRACHEOSTOMY TUBE. THE ISSUE WAS IDENTIFIED AT THE HOSPITAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21657415 ↗
• InjuryMar 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS PUT IN PLACE ON A PATIENT, AND AFTER ONE DAY, AIR LEAKAGE WAS NOTED ON THE CUFF AND ON THE BALLOON, DEFLATION WAS NOTICED. THE BALLOON WAS INFLATED EVERY 3 HOURS, AND THE TRACHEOSTOMY TUBE WAS INTENDED TO REMAIN FOR 7 DAYS. UPON CHANGING THE TUBE, LEAKAGE AT THE JUNCTION BETWEEN THE BALLOON AND THE TUBE WAS OBSERVED, CONFIRMED BY A WATER TEST. A DIFFERENT TUBE WAS PLACED ON THE PATIENT. THE CUSTOMER MADE 2 BRONCHIAL FIBROSCOPIES TO MAKE SURE THAT EVERYTHING WAS OK WITH THE PATIENT BECAUSE OF THE DEFLATING CUFF BUT EVERYTHING WAS FINE.

  Patient problems: Unintended Extubation

  MAUDE report 21639928 ↗
• MalfunctionMar 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE TRACHEOSTOMY TUBE WAS NOT SHOWING ADEQUATE BALLOON FUNCTION, WHEN IT WAS INFLATED, IT DID NOT MAINTAIN PRESSURE AND QUICKLY DEFLATES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559387 ↗
• MalfunctionFeb 13, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT, THE TRACHEOSTOMY TUBE'S CUFF HAD A LEAK. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 21374004 ↗
• MalfunctionJan 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION, A TINY HOLE WAS NOTICED FROM THE FOUR TRACHEOSTOMY TUBES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256549 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150844. One submission often covers many models, so check the product and lot details in each record.

• Z-1390-2025 · Feb 26, 2025 · Open, Classified
  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R