Shiley 10UN10RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521205543), received between Nov 22, 2022 and Feb 16, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K150844); they may or may not involve this specific model.

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.

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE SIDES OF THE TUBING WERE CRACKING AND BREAKING AFTER TWO WEEKS OF USE WHICH RESULTED PATIENT'S THROAT BEING IRRITATED SORE. THE OPENING ON THE PATIENT'S THROAT WAS ALSO SORE.

  Patient problems: Pressure Sore/Ulcer; Skin Inflammation/ Irritation; Unspecified Tissue Injury

  MAUDE report 16385125 ↗
• MalfunctionFeb 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE SIDES OF THE TUBING WERE CRACKING AND BREAKING AFTER TWO WEEKS OF USE WHICH RESULTED PATIENT'S THROAT BEING IRRITATED SORE. THE OPENING ON THE PATIENT'S THROAT WAS ALSO SORE.

  Patient problems: Pressure Sore/Ulcer; Skin Inflammation/ Irritation; Unspecified Tissue Injury

  MAUDE report 16385110 ↗
• MalfunctionNov 22, 2022Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE OLDER STYLE TUBES WERE A MORE RIGID, HARDER PLASTIC, AND WERE WELL SUITED TO ALLOW THE SECRETIONS THAT DID NOT EXIT THROUGH THE TRACH TUBE TO PASS BY AND BE COUGHED UP INTO THE THROAT FOR SUCTION, WHILE THE SOFTER, MORE FLEXIBLE, MATERIAL THAT THE NEWER TUBES ARE MADE OF WAS MUCH, STICKIER. THE SECRETIONS DO NOT PASS THE TUBE BY SO READILY AND INSTEAD STICK TO THE OUTSIDE OF THE TUBE CAUSING IT TO IRRITATE THE BRONCHIAL TUBE CAUSING SOMETIMES EXTREME COUGHING UNTIL THE TUBE PULLED OUT ANDCLEANED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15844262 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150844. One submission often covers many models, so check the product and lot details in each record.

• Z-1390-2025 · Feb 26, 2025 · Open, Classified
  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R