Shiley 6CN75HRecalls & reported problems

Summary

The FDA's MAUDE database contains 240 adverse event reports that list this exact device (DI 20884521176321), received between Jun 5, 2018 and Mar 10, 2026 — classified as 3 deaths, 36 injuries, 201 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (87 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 240 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE, THE PACKAGING CHANGE FOR THE FLEXIBLE ADULT TRACHEOSTOMY TUBES WITH DISPOSABLE INNER CANNULAS POSED A SAFETY THREAT DUE TO THE PRODUCT SIZING NOT BEING CLEARLY IDENTIFIED. THE UPDATED PRODUCT PACKAGING AND REFERENCE CODE CHANGES RESULTED IN THE SIZE OF THE TRACHEOSTOMY TUBE NOT BEING VISIBLE TO THE USER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563220 ↗
• MalfunctionDec 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING TRACH CHANGE DUE TO HOLE ON THE ANTERIOR SIDE. A NEW TRACH WAS PLACED WITHOUT INCIDENT. AFTER A FEW DAYS A LEAK WAS NOTED AND TUBE WAS REPLACED. IT WAS OBSERVED THAT IT WAS THE SAME ISSUE THAT OF THE HOLE IN THE ANTERIOR SIDE.

  Patient problems: Unintended Extubation

  MAUDE report 23694713 ↗
• MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT POST-OPERATIVELY, THE TRACH TUBE THAT WAS REMOVED DURING REPLACEMENT HAD A HOLE FOUND ON THE ANTERIOR SIDE OF THE CUFF. THE REPLACEMENT TRACH TUBE HAD THE SAME ISSUE BUT WAS RETAINED FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617866 ↗
• MalfunctionNov 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF ON THE PATIENT'S TRACHEOSTOMY TUBE WAS DEFLATING AND NOT HOLDING PRESSURE DURING USE. THE PATIENT EXPERIENCED GURGLING SOUNDS INDICATIVE OF AN AIR LEAK. THE SPOUSE WAS ABLE TO ATTEND TO THE PATIENT; THEREFORE, NO HARM OCCURRED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452469 ↗
• MalfunctionNov 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF ON THE PATIENT'S TRACHEOSTOMY TUBE WAS DEFLATING AND NOT HOLDING PRESSURE DURING USE. THE PATIENT EXPERIENCED GURGLING SOUNDS INDICATIVE OF AN AIR LEAK. THE SPOUSE WAS ABLE TO ATTEND TO THE PATIENT, THEREFORE NO HARM OCCURRED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452319 ↗
• MalfunctionOct 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, BOTH TRACH TUBE'S CUFF BLEW. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303192 ↗
• MalfunctionOct 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, BOTH TRACH TUBE'S CUFF BLEW. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302471 ↗
• 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 22836009 ↗
• MalfunctionJul 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THREE TRACHEOSTOMY TUBES WERE NOT HOLDING AIR DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668767 ↗
• MalfunctionJul 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THREE TRACHEOSTOMY TUBES WERE NOT HOLDING AIR DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668674 ↗
• MalfunctionJul 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THREE TRACHEOSTOMY TUBES WERE NOT HOLDING AIR DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668666 ↗
• MalfunctionJul 21, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACH TUBE'S CUFF WILL NOT STAY INFLATED AFTER INSERTION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22559939 ↗
• MalfunctionJun 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE TWO TRACHEOSTOMY TUBE HAD LEAK PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367402 ↗
• MalfunctionMay 19, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ROUTINE TRACH CHANGE DONE WITH SAME TYPE AND SIZE OF TRACH AS PREVIOUS. AFTER THE TRACH CHANGE, THE PATIENT EITHER BECOMES IMMEDIATELY SHORT OF BREATH ONCE OFF THE VENT (USING THE SPEAKING VALVE) OR NOTICES INTERMITTENT SHORTNESS OF BREATH THROUGHOUT THE DAY WHILE ON HIS SPEAKING VALVE. ALSO NOTICES SOME INTERMITTENT DIFFICULTIES WITH SPEAKING WHILE ON THE VENT, DEPENDING ON POSITIONING OF THE TRACH. THIS WAS ALSO ALLEVIATED WHEN THE TRACH TUBE WAS PUSHED UP TOWARDS HIS CHIN.

  Patient problems: Insufficient Information

  MAUDE report 22043830 ↗
• InjuryMay 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ROUTINE TRACH CHANGE WAS DONE WITH SAME TYPE AND SIZE OF TRACH AS PREVIOUS. AFTER THE TRACH CHANGE, THE PATIENT EITHER BECAME IMMEDIATELY SHORT OF BREATH ONCE OFF THE VENT (USING THE SPEAKING VALVE) OR NOTICED AN INTERMITTENT SHORTNESS OF BREATH THROUGHOUT THE DAY WHILE ON HIS SPEAKING VALVE. SOME INTERMITTENT DIFFICULTIES WITH SPEAKING WHILE ON THE VENT WAS ALSO NOTICED, DEPENDING ON POSITIONING OF THE TRACH. THIS WAS ALLEVIATED WHEN THE TRACH TUBE WAS PUSHED UP TOWARDS HIS CHIN.

  Patient problems: Dyspnea; Respiratory Failure; Unintended Extubation

  MAUDE report 22002031 ↗
• MalfunctionFeb 25, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE FOUR TRACHEOSTOMY TUBES WERE NOT INFLATING AND HAD A LEAK. WHILE THE OTHER CUFF "RUPTURED". THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455449 ↗
• MalfunctionFeb 25, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE FOUR TRACHEOSTOMY TUBES WERE NOT INFLATING AND HAD A LEAK. WHILE THE OTHER CUFF "RUPTURED". THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455438 ↗
• MalfunctionFeb 25, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE FOUR TRACHEOSTOMY TUBES WERE NOT INFLATING AND HAD A LEAK. WHILE THE OTHER CUFF "RUPTURED". THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455434 ↗
• MalfunctionFeb 5, 2025Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  IT WAS REPORTED THAT A 7.5MM SHIL CUFFED TRACH CANNULA EXPERIENCED A CUFF INFLATION/DEFLATION ISSUE AND HAD A HOLE IN THE CUFF. THE ISSUE WAS DISCOVERED IN THE OR WHEN THE SURGEON WAS PLACING THE TRACH. THE PRODUCT WAS REPLACED BY A MEDTRONIC PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315961 ↗
• InjuryJan 30, 2025Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE OF A 7.5MM SHIL CUFFED TRACH THE PATIENT WAS IN RESPIRATORY DISTRESS DUE TO THE CUFF NOT PROPERLY INFLATING. THERE WAS A HOLE FOUND IN THE BODY OF THE TRACH IN THE MIDDLE OF THE CUFF. THE EVENT OCCURRED IN A HOSPITAL SETTING, AND EVERY TIME THE PATIENT COUGHED, THE CUFF WOULD INFLATE. A RESPIRATORY THERAPIST REMOVED THE TRACH AND IDENTIFIED THE HOLE. A NEW TRACH WAS PLACED WITHOUT ANY ISSUES.

  Patient problems: Adult Respiratory Distress Syndrome; Cough; Respiratory Insufficiency; Unintended Extubation

  MAUDE report 21280408 ↗
• MalfunctionJan 29, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A TRACHEOSTOMY DEVICE PERSISTENTLY LOST CUFF PRESSURE DURING USE. THE CUFF WAS TESTED AND FOUND TO BE LOSING AIR IMMEDIATELY UPON INFLATION. A REPLACEMENT OF THE TUBE WAS PERFORMED.

  Patient problems: Unintended Extubation

  MAUDE report 21263274 ↗
• MalfunctionOct 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT SUSTAINED IRRITATION DESCRIBED AS A 'FLAP' AT THE BASE OF THE TRACH. ISSUE OCCURRED AFTER USING A NEW MODEL OF THE TRACHEOSTOMY TUBE. THE PATIENT SWITCHED BACK TO THE OLDER MODEL.

  Patient problems: Inflammation; Skin Inflammation/ Irritation; Unintended Extubation

  MAUDE report 20343625 ↗
• MalfunctionJun 28, 2024Disconnection; Connection Problem; Disconnection; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CANNULA WAS EASILY POPPING OFF FROM THE PATIENT'S CONNECTOR. RE-CANNULATION AND REPLACEMENT OF THE TUBE WAS NOT REQUIRED BECAUSE A TRACHEOSTOMY TIE WAS USED TO SECURE THE TUBE UNTIL THE NEXT ROUTINE TRACHEOSTOMY CHANGE WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633799 ↗
• MalfunctionJun 27, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING USE, THE CANNULA WAS EASILY POPPED OFF FROM THE PATIENT'S CONNECTOR. RE-CANNULATION AND REPLACEMENT OF THE TUBE WAS NOT REQUIRED BECAUSE A TRACHEOSTOMY TIE WAS USED TO SECURE THE TUBE UNTIL THE NEXT ROUTINE TRACHEOSTOMY CHANGE WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624971 ↗
• MalfunctionJun 27, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING USE, THE CANNULA WAS EASILY POPPED OFF FROM THE PATIENT'S CONNECTOR. RE-CANNULATION AND REPLACEMENT OF THE TUBE WAS NOT REQUIRED BECAUSE A TRACHEOSTOMY TIE WAS USED TO SECURE THE TUBE UNTIL THE NEXT ROUTINE TRACHEOSTOMY CHANGE WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624914 ↗