Shiley 8UN85HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884521176277), received between Jan 18, 2023 and Oct 22, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 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 23356980 ↗
• MalfunctionOct 22, 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 23356930 ↗
• MalfunctionOct 22, 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 23356790 ↗
• MalfunctionOct 22, 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 23356707 ↗
• 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 23339354 ↗
• 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 23339137 ↗
• MalfunctionApr 16, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY CUFF HAD A SLOW LEAK AND WAS BEING REFILLED WITH ABOUT 3 CC OF AIR ONCE PER DAY. A CALL WAS RECEIVED THAT THE VENTILATOR WAS SOUNDING A LOW AIR ALARM, WENT TO REFILL THE TRACHEOSTOMY WITH MORE AIR AND COULD NOT RE-INFLATE THE CUFF. THE TUBE HAS BEEN REPLACED WITH A NEW ONE.

  Patient problems: Unintended Extubation

  MAUDE report 19117559 ↗
• InjuryJun 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT WAS ON AIRWAY ANTIBIOTICS AND HAD A TUBE REPLACEMENT. AFTER THE REPLACEMENT, THE PATIENT WAS "COUGHING OUT A LITTLE BLOOD AND HAD BLEEDING".

  Patient problems: Hemoptysis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17106025 ↗
• MalfunctionJan 18, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE PLUG WOULD NOT FIT IN THE TRACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194184 ↗