Shiley 7CN80HRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 20884521176338), received between Jun 5, 2018 and Jun 3, 2025 — classified as 1 death, 7 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 24, 2023Class IOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT'S TRACHEOSTOMY CUFF WAS SPONTANEOUSLY INFLATING WHILE THE PATIENT HAD A PASSY-MUIR VALVE (PMV) ON. THE EVENT TOOK PLACE IN A HOSPITAL SETTING. THERE WAS NO PATIENT HARM.

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

  MAUDE report 22136564 ↗
• MalfunctionJul 26, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE FOLLOWING TRACHEOSTOMY TUBE'S CUFF WERE NOT DURABLE AND DID NOT STAY INFLATED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19844739 ↗
• MalfunctionJul 26, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE FOLLOWING TRACHEOSTOMY TUBE'S CUFF WERE NOT DURABLE AND DID NOT STAY INFLATED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19844711 ↗
• MalfunctionJul 26, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-USAGE INSPECTION, THE TRACHEOSTOMY TUBE'S CUFF WAS NOT DURABLE AND DID NOT STAY INFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844620 ↗
• InjuryJul 26, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING INTUBATION, THE TRACHEOSTOMY TUBE'S CUFF WAS DEFLATING WHEN BEING INSERTED INTO THE PATIENT IN A NORMAL AND CONTROLLED MANNER. THERE WAS AN EVIDENT HOLE IN THE CUFF, AND SUBSEQUENT LOW TIDAL VOLUME NOTED BY ANESTHESIA. THE TUBE WAS REPLACED AND EXTENDED THE DURATION OF THE BOARDED CASE.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 19839952 ↗
• InjuryJun 14, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA WAS REPLACED THREE TIMES IN THREE DAYS SPAN AND THE PATIENT WAS NOT RECEIVING ADEQUATE MECHANICAL VENTILATION. THE RESPIRATORY THERAPIST INVOLVED IN SECOND THIRD TRACH REPLACEMENT REALIZED THAT THE SAME LOT NUMBER WAS BEING USED IN REPLACEMENTS AND FAILING IN THE SAME SPOT OF THE CUFF WHEN TESTED AFTER REMOVAL.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 19536868 ↗
• InjuryJun 14, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA WAS REPLACED THREE TIMES IN THREE DAYS SPAN AND THE PATIENT WAS NOT RECEIVING ADEQUATE MECHANICAL VENTILATION. THE RESPIRATORY THERAPIST INVOLVED IN SECOND THIRD TRACH REPLACEMENT REALIZED THAT THE SAME LOT NUMBER WAS BEING USED IN REPLACEMENTS AND FAILING IN THE SAME SPOT OF THE CUFF WHEN TESTED AFTER REMOVAL.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 19536841 ↗
• InjuryJun 14, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA WAS REPLACED THREE TIMES IN THREE DAYS SPAN AND THE PATIENT WAS NOT RECEIVING ADEQUATE MECHANICAL VENTILATION. THE RESPIRATORY THERAPIST INVOLVED IN SECOND <(>&<)> THIRD TRACH REPLACEMENT REALIZED THAT THE SAME LOT NUMBER WAS BEING USED IN REPLACEMENTS AND FAILING IN THE SAME SPOT OF THE CUFF WHEN TESTED AFTER REMOVAL.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 19536837 ↗
• MalfunctionApr 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTED, THE TRACHEOSTOMY TUBE'S CUFF OR PILOT BALLOON HAD CONDENSATION DURING USE. THE PHYSICIAN PULLED 3ML OF AIR OUT OF THE CUFF AND WHEN THE PATIENT COUGHED THE CUFF RE-INFLATED AND ANOTHER 2ML OF AIR WAS TAKEN OUT. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19072898 ↗
• InjuryMar 26, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DEFLATED WITH TRACH CAP IN PLACE, HAD CONDENSATION AND INCREASED RESISTANCE. THE PATIENT WAS ADMITTED DUE TO INCREASED SECRETIONS IN THE PILOT BALLOON, HYPOXIA, INCREASED WORK OF BREATHING, AND SHORTNESS OF BREATH. THE TRACH WAS REPLACED.

  Patient problems: Hypoxia; Unintended Extubation

  MAUDE report 18978908 ↗
• MalfunctionJan 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF WAS LEAKING WHEN PLACED AFTER SIX HOURS. THE TUBE WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 18432136 ↗
• MalfunctionJun 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A SMALL PIECE AT THE TOP OF THE TRACHEOSTOMY'S CUFF FLAPPED OVER AND PULLED AWAY FROM THE TUBE CAUSING A LEAK AFTER THE PROCEDURE. THE TUBE WAS REPLACED.

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

  MAUDE report 17181038 ↗
• MalfunctionApr 5, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS UNABLE TO PROVIDE ARTIFICIAL AIRWAY FOR MECHANICAL VENTILATION DUE TO RUPTURED CUFF DURING TESTING. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682234 ↗
• MalfunctionNov 4, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF HAD A HOLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729869 ↗
• MalfunctionNov 4, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF HAS HOLES IN IT. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727953 ↗
• MalfunctionJun 17, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, A 8.0MM TRACH WAS USED TO A REGULAR PATIENT. POST-PROCEDURE THEY WENT TO THE OPERATING ROOM WHERE THEY WERE VENTILATED. THE PATIENT HAD SIGNIFICANT LEAKS WHERE EVEN A SIZE 10MM WOULD NOT SEAL THE TRACH. EVENTUALLY, THE TRACH WAS CHANGED TO XLT DUE TO THE SIZE OF THE CUFF. THERE WAS NO DAMAGE WITH THE CUFF.

  Patient problems: Unintended Extubation

  MAUDE report 14738644 ↗
• MalfunctionMay 5, 2022Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE DEVICE DID NOT SEAL THE AIRWAY PROPERLY AND HAD A LEAK. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 14287999 ↗
• DeathApr 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, A PATIENT WITH A DIFFICULT AIRWAY HAD AN UNANTICIPATED EXTUBATION. THE PATIENT WAS ON A TRACH COLLAR AND OFF THE VENT PRIOR TO THE EVENT AND THE CUFF WAS DEFLATED. THE CUFF WAS INFLATED TO A MAXIMUM PRESSURE OF 100 AS THERE WAS A LEAK WITH THE SEATING/SEAL INSIDE THE TRACHEA. IT WAS DISPLACED INTO A FALSE TRACT. THE PATIENT WAS UNABLE TO BE REINTUBATED, CODED, AND EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 13994487 ↗
• MalfunctionFeb 25, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS A CUFF LEAK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600389 ↗
• MalfunctionJan 25, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT'S TRACHEOSTOMY TUBE HAD TO BE CHANGED OUT BECAUSE OF A CUFF FAILURE. AFTER THE TRACHEOSTOMY TUBE WAS CHANGED, IT HAD TO BE CHANGED AGAIN AFTER 2 HOURS BECAUSE IT HAD CUFF ISSUE. THE PATIENT ENDED UP SWITCHING TO A SIZE 7 TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 13351041 ↗
• MalfunctionJan 25, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT'S TRACHEOSTOMY TUBE HAD TO BE CHANGED OUT BECAUSE OF A CUFF FAILURE. AFTER THE TRACHEOSTOMY TUBE WAS CHANGED, IT HAD TO BE CHANGED AGAIN AFTER 2 HOURS BECAUSE IT HAD CUFF ISSUE. THE PATIENT ENDED UP SWITCHING TO A SIZE 7 TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 13351019 ↗
• MalfunctionMay 11, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF BALLOON WAS DEFLATING WHEN THE PRE-USE TEST INFLATION WAS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805635 ↗
• MalfunctionOct 21, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S LABEL WAS ILLEGIBLE. THE PATIENT WAS READMITTED WITH THE SAME DEVICE BUT THE LABEL WAS NO LONGER AVAILABLE AND THE COLOR TAG HAD ALMOST WORN OFF OF THE FLANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216651 ↗
• MalfunctionOct 15, 2019Crack; Crack

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CRACKED INNER CANNULA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9191302 ↗
• InjuryMay 21, 2019Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE PATIENT WAS NOT RECEIVING TIDAL VOLUMES FROM THE VENTILATOR. 3CC WAS WITHDRAWN VIA THE PILOT BALLOON AND 8CC WAS ADDED BACK IN AN ATTEMPT TO PERFORM MINIMAL LEAK TECHNIQUE. THE CUFF WAS NOT ABLE TO BE ADEQUATELY FILLED WITH AIR. A TEAR ON THE CUFF WAS FOUND. THE PATIENT WAS RECANNULATED.

  Patient problems: Extubate

  MAUDE report 8629415 ↗