Shiley 80XLTINRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 50884522006741), received between Aug 16, 2021 and Jun 2, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Defective Component” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Disconnection; Use of Device Problem; Disconnection; Use of Device Problem

  IT WAS REPORTED THAT WHEN THE RESPIRATORY THERAPIST INSERTED A NEW CANNULA INTO THE PATIENT AND TRIED TO LOCK IT IN PLACE USING THE BLUE LOCKING RING, THE LOCKING RING BECAME COMPLETELY DETACHED FROM THE CANNULA. THE ISSUE WAS IMMEDIATELY IDENTIFIED AND THE CANNULA WAS SAFELY REMOVED FROM THE PATIENT AND REPLACED WITH A NEW CANNULA.

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

  MAUDE report 22122155 ↗
• MalfunctionJul 22, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE INNER CANNULA WAS UNABLE TO FIT INTO THE TRACHEOSTOMY TUBE, AND IT WAS FOUND TO BE KINKED. TRIED ANOTHER INNER CANNULA, AND IT WAS ALSO KINKED. WAS ABLE TO FINALLY GET AN INNER CANNULA TO FIT IN THE TRACHEOSTOMY TUBE AFTER THE SECOND CANNULA. IT WAS ALSO MENTIONED THAT THE CUFF DID NOT HOLD AIR. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802431 ↗
• MalfunctionJul 22, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE INNER CANNULA WAS UNABLE TO FIT INTO THE TRACHEOSTOMY TUBE, AND IT WAS FOUND TO BE KINKED. TRIED ANOTHER INNER CANNULA, AND IT WAS ALSO KINKED. WAS ABLE TO FINALLY GET AN INNER CANNULA TO FIT IN THE TRACHEOSTOMY TUBE AFTER THE SECOND CANNULA. IT WAS ALSO MENTIONED THAT THE CUFF DID NOT HOLD AIR. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19799095 ↗
• MalfunctionJul 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AN ATTEMPT WAS MADE TO INSERT A NEW TRACHEOSTOMY DISPOSABLE INNER CANNULA IN A PATIENT AND THE BLUE TWIST BROKE OFF UPON INITIAL INSERTION BASED ON THE PHOTO PROVIDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19732098 ↗
• MalfunctionApr 24, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED A BOX OF TEN INNER CANNULAS ON (B)(6)AND HAD TO USED THEM ALL, AS THE TRACHEOSTOMY CANNULA'S UPPER SECTION COULD NOT HOLD THE STRUCTURE AND WOULD COLLAPSED WHEN TRIED TO PUSH IN DURING USE. THE REGISTERED RESPIRATORY THERAPIST WHO ASSISTED THE PATIENT NOTICED THE SAME ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173973 ↗
• MalfunctionApr 24, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED A BOX OF TEN INNER CANNULAS ON (B)(6) AND HAD TO USED THEM ALL, AS THE TRACHEOSTOMY CANNULA'S UPPER SECTION COULD NOT HOLD THE STRUCTURE AND WOULD COLLAPSED WHEN TRIED TO PUSH IN DURING USE. THE REGISTERED RESPIRATORY THERAPIST WHO ASSISTED THE PATIENT NOTICED THE SAME ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173914 ↗
• MalfunctionApr 24, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED A BOX OF TEN INNER CANNULAS ON MARCH 7TH AND HAD TO USED THEM ALL, AS THE TRACHEOSTOMY CANNULA'S UPPER SECTION COULD NOT HOLD THE STRUCTURE AND WOULD COLLAPSED WHEN TRIED TO PUSH IN DURING USE. THE REGISTERED RESPIRATORY THERAPIST WHO ASSISTED THE PATIENT NOTICED THE SAME ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173873 ↗
• MalfunctionApr 24, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED A BOX OF TEN INNER CANNULAS ON MARCH 7TH AND HAD TO USED THEM ALL, AS THE TRACHEOSTOMY CANNULA'S UPPER SECTION COULD NOT HOLD THE STRUCTURE AND WOULD COLLAPSED WHEN TRIED TO PUSH IN DURING USE. THE REGISTERED RESPIRATORY THERAPIST WHO ASSISTED THE PATIENT NOTICED THE SAME ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173773 ↗
• MalfunctionApr 24, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED A BOX OF TEN INNER CANNULAS ON (B)(6)AND HAD TO USED THEM ALL, AS THE TRACHEOSTOMY CANNULA'S UPPER SECTION COULD NOT HOLD THE STRUCTURE AND WOULD COLLAPSED WHEN TRIED TO PUSH IN DURING USE. THE REGISTERED RESPIRATORY THERAPIST WHO ASSISTED THE PATIENT NOTICED THE SAME ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173499 ↗
• MalfunctionApr 24, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED A BOX OF TEN INNER CANNULAS ON (B)(6)AND HAD TO USED THEM ALL, AS THE TRACHEOSTOMY CANNULA'S UPPER SECTION COULD NOT HOLD THE STRUCTURE AND WOULD COLLAPSED WHEN TRIED TO PUSH IN DURING USE. THE REGISTERED RESPIRATORY THERAPIST WHO ASSISTED THE PATIENT NOTICED THE SAME ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173440 ↗
• MalfunctionApr 24, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED A BOX OF TEN INNER CANNULAS ON MARCH 7TH AND HAD TO USED THEM ALL, AS THE TRACHEOSTOMY CANNULA'S UPPER SECTION COULD NOT HOLD THE STRUCTURE AND WOULD COLLAPSED WHEN TRIED TO PUSH IN DURING USE. THE REGISTERED RESPIRATORY THERAPIST WHO ASSISTED THE PATIENT NOTICED THE SAME ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173424 ↗
• MalfunctionApr 24, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED A BOX OF TEN INNER CANNULAS ON MARCH 7TH AND HAD TO USED THEM ALL, AS THE TRACHEOSTOMY CANNULA'S UPPER SECTION COULD NOT HOLD THE STRUCTURE AND WOULD COLLAPSED WHEN TRIED TO PUSH IN DURING USE. THE REGISTERED RESPIRATORY THERAPIST WHO ASSISTED THE PATIENT NOTICED THE SAME ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173390 ↗
• MalfunctionApr 24, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED A BOX OF TEN INNER CANNULAS ON MARCH 7TH AND HAD TO USED THEM ALL, AS THE TRACHEOSTOMY CANNULA'S UPPER SECTION COULD NOT HOLD THE STRUCTURE AND WOULD COLLAPSED WHEN TRIED TO PUSH IN DURING USE. THE REGISTERED RESPIRATORY THERAPIST WHO ASSISTED THE PATIENT NOTICED THE SAME ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173365 ↗
• MalfunctionJan 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, UPON PUTTING SCOPE IN THE PATIENT'S AIRWAY FOR BRONCHOSCOPY, PIECES OR FRAGMENTS OF A RECENT DISPOSABLE INNER CANNULA WAS DISCOVERED AFTER REMOVING TRACH FULLY FROM STOMA. FRAGMENTS WERE STILL INTACT WITH TRACH, NO FRAGMENTS FOUND AFTER CONTINUING THE PROCEDURE. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18506892 ↗
• MalfunctionMar 27, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WAS FOUND DEFECTIVE. THE TRACH WOULD NOT STAY SEATED, SNAP IN PLACE AND COMES OUT WHEN THE PATIENT COUGH. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 16618487 ↗
• MalfunctionFeb 9, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE. THE DEVICE INNER CANNULA WAS DEFECTIVE. THE TRACH WOULD NOT STAY SEATED AND SNAP IN PLACE; IT COMES OUT WHEN THE PATIENT COUGHS. REPLACEMENT OF THE TUBE WAS DONE.

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

  MAUDE report 16334480 ↗
• MalfunctionFeb 8, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE. THE DEVICE INNER CANNULA WAS DEFECTIVE. THE TRACH WOULD NOT STAY SEATED AND SNAP IN PLACE. THE INNER CANNULA COMES OUT WHEN THE PATIENT COUGH. TUBE WAS REPLACED.

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

  MAUDE report 16323448 ↗
• MalfunctionAug 16, 2021Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DISPOSABLE INNER CANNULAS HAVE BROKEN OFF AT THE TOP WHEN TWISTED ONTO THE TRACH TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324809 ↗