Shiley 4UN65HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20884521176239), received between Nov 19, 2018 and Oct 18, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE BROKE OFF AT THE BASE PLATE THAT CREATED AN UNSECURED TUBE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17962016 ↗
• MalfunctionOct 18, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE BROKE OFF AT THE BASE PLATE THAT CREATED AN UNSECURED TUBE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17960315 ↗
• MalfunctionSep 12, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INNER CANNULA DID NOT LOCK AND DID NOT REMAIN IN PLACE WITHIN THE 15 MM CONNECTOR DURING A TRACH CHANGE. THE RESPIRATORY THERAPIST (RT) TRIED WITH A CANNULA THAT THE PATIENT HAD AND IT ALSO DID NOT LOCK. THE RESPIRATORY THERAPIST HAD TO REPLACE THE TRACH WITH THE ONE THAT WAS JUST REMOVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733309 ↗
• MalfunctionSep 12, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INNER CANNULA DID NOT LOCK AND DID NOT REMAIN IN PLACE WITHIN THE 15 MM CONNECTOR DURING A TRACH CHANGE. THE RESPIRATORY THERAPIST (RT) TRIED WITH A CANNULA THAT THE PATIENT HAD AND IT ALSO DID NOT LOCK. THE RESPIRATORY THERAPIST HAD TO REPLACE THE TRACH WITH THE ONE THAT WAS JUST REMOVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731269 ↗
• MalfunctionFeb 20, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS DIFFICULT TO CLEAN DUE TO THE INCREASED IN LENGTH THAT STICKS OUT FROM THE PATIENT'S THROAT AND THE CAP WAS DETACHED WHEN THE PATIENT COUGHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406336 ↗
• MalfunctionJun 13, 2022Crack; Crack

  ACCORDING TO THE REPORTER, THE PATIENT WAS A FRESH TRACH WHICH REQUIRES SUCTIONING WITH A SOFT RED ¿RUBBER¿ CATHETER.  DURING SUCTIONING, THE PATIENT WAS UNABLE TO PASS SUCTION CATHETER. THE PATIENT WAS BEING MANUALLY VENTILATED, THEY INITIALLY THOUGHT IT WAS DUE TO SUSPECTED MUCOUS PLUGGED, HOWEVER UPON REMOVAL OF INNER CANNULA IT WAS DETERMINED TO HAVE MULTIPLE CRACKS IN THE INNER CANNULA. THERE WAS NO HARM DURING THE INNER CANNULA CHANGE, VITAL SIGNS WERE STABLE.

  Patient problems: Unintended Extubation

  MAUDE report 14676389 ↗
• MalfunctionNov 19, 2018Inadequacy of Device Shape and/or Size

  INSERTION OF A SIZE 4 INNER TRACH CANNULA - IN METRIC IT'S LISTED AS 6.5 MM ON THE PACKAGING AND THIS WAS INTERPRETED AS US SIZE 6 INNER TRACH CANNULA. MANUFACTURER RESPONSE FOR DISPOSABLE INNER CANNULA, SHILEY (PER SITE REPORTER). MANUFACTURER STATES THEY ARE AWARE OF ISSUE AND ARE IN PROCESS OF CHANGING PACKAGE LABELING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8083891 ↗