Shiley 4CN65HRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 20884521176307), received between Dec 15, 2017 and May 22, 2026 — classified as 1 death, 15 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (7 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Obstruction of Flow

  ACCORDING TO THE REPORTER, THE PATIENT WAS USING A TRACHEOSTOMY TUBE. THE EMERGENCY MEDICAL TECHNICIANS WERE CALLED TO THE PATIENT'S HOME FOR "BREATHING PROBLEMS". "TRACH BLOCKAGE," "FOREIGN OBJECT IN TRACH," AND "TRACH NOT OPERATING PROPERLY" WERE NOTED. THE PATIENT WAS TRACHEOSTOMY-DEPENDENT FOR RESPIRATION.

  Patient problems: Dyspnea

  MAUDE report 25260257 ↗
• InjuryMay 22, 2026Obstruction of Flow

  ACCORDING TO THE REPORTER, THE PATIENT WAS USING A TRACHEOSTOMY TUBE. THE EMERGENCY MEDICAL TECHNICIANS WERE CALLED TO THE PATIENT'S HOME FOR "BREATHING PROBLEMS". "TRACH BLOCKAGE," "FOREIGN OBJECT IN TRACH," AND "TRACH NOT OPERATING PROPERLY" WERE NOTED. THE PATIENT WAS TRACHEOSTOMY-DEPENDENT FOR RESPIRATION AND WAS HOSPITALIZED FOR BREATHING ISSUES RELATED TO THE TRACH BLOCKAGE.

  Patient problems: Dyspnea

  MAUDE report 25260169 ↗
• InjuryNov 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF HAD BLOWN HOLES FROM A PATIENT RECEIVING COUGH ASSIST TREATMENT THREE TIMES A DAY. THERE WAS REPORTED COMPLICATION/HARM TO THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23532362 ↗
• MalfunctionNov 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF HAD BLOWN HOLES FROM A PATIENT RECEIVING COUGH ASSIST TREATMENT THREE TIMES A DAY. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 23532342 ↗
• MalfunctionNov 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF HAD BLOWN HOLES FROM A PATIENT RECEIVING COUGH ASSIST TREATMENT THREE TIMES A DAY. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 23532278 ↗
• 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 23339757 ↗
• 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 23335591 ↗
• MalfunctionJul 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE 6.5 MM TRACHEOSTOMY CANNULA WAS ASSOCIATED WITH A CUFF THAT WAS NOT HOLDING PRESSURE, RESULTING IN CUFF LEAKS. THE EVENT OCCURRED IN A HOSPITAL SETTING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472124 ↗
• MalfunctionMay 16, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S BALLOON DID NOT INFLATE DURING USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19337202 ↗
• InjuryApr 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE WAS NOTED WITH LEAK AND LOW VOLUMES FROM THE PATIENT FOR A FEW SECONDS. AN EMERGENCY UPSIZE TRACH CHANGE WAS DONE. PATIENT WAS PLACED BACK ON MECHANICAL VENTILATOR WITH SAME SETTINGS AND VITAL SIGN WERE STABLE.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 19119950 ↗
• MalfunctionApr 16, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD FITMENT ERRORS TO THE FILTER DURING USE. A TAPE WAS USED TO FILL THE GAP BETWEEN THE TRACH AND FILTER ATTACHMENT TO AVOID LEAKS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119594 ↗
• MalfunctionApr 16, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD FITMENT ERRORS TO THE FILTER DURING USE. A TAPE WAS USED TO FILL THE GAP BETWEEN THE TUBE AND THE FILTER. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119354 ↗
• MalfunctionApr 3, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF "BURST/BLOWN" DURING PATIENT USE. THE TUBE WAS REMOVED AND REPLACED, NO RESPIRATORY DISTRESS WAS NOTED.

  Patient problems: Unintended Extubation

  MAUDE report 19032923 ↗
• InjuryApr 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD A LEAK AND LOW VOLUMES DURING PATIENT USE. THE DOCTOR PERFORMED AN EMERGENCY TRACH CHANGE WITH UPSIZED TRACH. PATIENT WAS PLACED BACK ON MECHANICAL VENTILATOR WITH SAME SETTINGS, VITAL SIGNS WERE STABLE.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 19032521 ↗
• InjuryFeb 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT WAS NOT MAINTAINING ADEQUATE TIDAL VOLUMES AND THE RESPIRATORY CARE PRACTITIONER PERFORMED AN EMERGENT TRACH TUBE CHANGE WITH THE SAME SIZE. THE PATIENT WAS MONITORED THROUGHOUT WITH NO COMPLICATIONS.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 18808962 ↗
• DeathAug 13, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE PATIENT WAS A HOME CARE PATIENT, THAT WAS USING AN ADULT TRACHEOSTOMY TUBE, AND WAS CONNECTED TO A VENTILATOR. THE REPORTER STATED THE PATIENT ¿WAS UNABLE TO BREATHE¿ AS AIR WAS UNABLE TO GET IN PAST THE TRACHEOSTOMY TUBE. THE VENTILATOR WAS CHECKED AND SHOWED NORMAL OPERATION. IT WAS ADDITIONALLY REPORTED THAT EMERGENCY RESPONSE (911) WAS CALLED, AND UPON ARRIVAL; MEDICATION, HEART PUMP AND MANUAL VENTILATION VIA AMBU BAG WERE APPLIED BY THE MEDICAL RESPONDERS WITH NEGATIVE RESULTS. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL BUT DIED. THE REPORTER STATED THE MEDICAL EXAMINER¿S REPORT ATTRIBUTED THE DEATH TO CARDIAC ARREST THAT RESULTED FROM MUCOUS IN THE TRACH WHICH PREVENTED AIR FROM GETTING INTO THE PATIENT¿S SYSTEM.

  Patient problems: Airway Obstruction; Cardiac Arrest; Dyspnea; Hypoventilation; Loss of consciousness; Respiratory Failure

  MAUDE report 17538030 ↗
• InjuryMay 4, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT "PULLED THE CUFF DOWN" TO PLACE THE SPEAKING VALVE AND IT "REFLATED" WITH HEALTHCARE PROVIDERS AT THE BEDSIDE IN SHORT DURATION. THE PATIENT HAD AN UNKNOWN INJURY.

  Patient problems: Respiratory Insufficiency; Tachycardia; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 16868170 ↗
• InjuryApr 11, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE WAS PLACED ON THE PATIENT IN ACCORDANCE WITH HOSPITAL POLICY, AND THE RESPIRATORY CARE PROFESSIONAL (RCP) OBSERVED THAT THE PATIENT HAD INCREASED WORK OF BREATHING (WOB), TACHYCARDIA, AND DESATURATION. RCP ATTEMPTED TROUBLESHOOTING BY INFLATING THE PILOT BALLOON WITH A 10CC SYRINGE, BUT THE PILOT BALLOON WAS UNABLE TO MAINTAIN AIR PRESSURE AND WAS ACTIVELY DEFLATING. A REPLACEMENT OF THE DEVICE WAS PERFORMED AS AN EMERGENCY.

  Patient problems: Dyspnea; Low Oxygen Saturation; Tachycardia; Unintended Extubation

  MAUDE report 16713171 ↗
• MalfunctionMar 3, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE SPEAKING VALVE POPPED OFF REGULARLY WHEN SPEECH WAS INITIATED WITH THE NEW TRACHEA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479852 ↗
• MalfunctionFeb 6, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, DURING USE, THE WRITING ON THE FLANGE WORE OFF WHEN CLEANED SO THE HOSPITAL WAS NOT ABLE TO DETERMINE WHAT SIZE DEVICE THE PATIENT HAD. THERE WAS A REQUIRED TUBE REPLACEMENT.

  Patient problems: Unintended Extubation

  MAUDE report 16309512 ↗
• MalfunctionJul 20, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS AN ISSUE WITH CAPPING A PATIENT. THE CAP DID NOT STAY ON THE HUB. TROUBLESHOOTED WITH MULTIPLE CAPS. SPEAKING VALVE, BECAUSE IT'S TAPERED WORKED FINE. MANUAL RESUSCITATION BAG ALSO WORKED BUT WOULD NEED TO BE HELD IN PLACE. WHICH NOT TYPICALLY MUCH OF THE TIME. TRIED MULTIPLE CAPS. THEY ALL SPIN AROUND AND SLID OR DROPPED OFF.

  Patient problems: Insufficient Information

  MAUDE report 15065939 ↗
• MalfunctionMar 16, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE DEVICE WAS RUPTURED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13781206 ↗
• InjuryAug 27, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT WENT BACK TO THE CLINIC AND HAD TO GO TO ER AS PATIENT WAS UNABLE TO GET OXYGEN. SATURATION WAS 93%-96% ON 10 LITERS. THE PATIENT WAS ADMITTED AND O2 WAS OKAY. SEEN BY THE PHYSICIAN AND WAS FOUND TO BE HYPERCAPNIC. SIZE 4 CUFFED WAS CHANGED TO SIZE 6, "6DIC" WHICH IMPROVED THE ISSUE WITH HIGH CO2 LEVELS. EVENTUALLY HAD AN EVENT WITH CHANGE TO A NEW VENT AND PASSED OUT AND WAS ADMITTED TO ICU. SHORTLY AFTERWARDS THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO HOME. THE PATIENT HAD A MEDICAL HISTORY OF ASTHMA AND SCOLIOSIS. REPORTED USING THE DCT MOSTLY WITH THE CUFF DEFLATED.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 12380940 ↗
• MalfunctionJul 5, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN AIR LEAKED. THE PATIENT HAD A CYANOSIS AND NEEDED ADDITIONAL OXYGEN FROM 2 LITERS TO 3 LITERS WITH EXERTION. IT WAS INDICATED THAT THE PATIENT FELT MORE AIRFLOW AROUND THE FLANGE AND ALSO STATED THAT NOW BREATHING IN AIR, THE AIR FEELS COLD. PATIENT WAS A VENTILATOR DEPENDENT AND DID NOT USE A SPEAKING VALVE WITH MEDICAL HISTORY OF ASTHMA AND SCOLIOSIS. PATIENT DID NOT MONITOR CUFF PRESSURE BUT INFLATED USING A SYRINGE TO DESIRED COMFORT OR DESIRED EFFECT. THE PATIENT HAD A CONTINUED SYMPTOMS DESCRIBED ON THE ORIGINAL REPORT.

  Patient problems: Cyanosis

  MAUDE report 12119307 ↗
• InjuryJan 3, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE OF THE DEVICE, IT HAD AN ISSUE WITH CUFF INFLATION/DEFLATION. THE CUFF WAS INFLATED TO 23 CMH2O AND WAS REDUCED TO 5-10 CMH20. THE TUBE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 7160455 ↗