Shiley 4UN65RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521205482), received between Aug 12, 2022 and Jun 28, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CANNULA WAS CLEANED WITH A 10 MM NYLON BRUSH WITH A SHARP METAL END. IT WAS FOUND OUT THAT THERE WAS A SCRATCH AND TEAR AT THE TIP OF THE INNER CANNULA, AS SHOWN IN THE ATTACHED PHOTO. THE REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19638427 ↗
• MalfunctionNov 28, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S FLANGE BROKE DURING USED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222935 ↗
• MalfunctionOct 12, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE SPEAKING VALVE WOULD NOT WORK ON THE DEVICE. IT DID NOT FIT SECURELY. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922822 ↗
• MalfunctionAug 9, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE WAS NOT HOLDING UP AND KEPT FALLING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17493222 ↗
• MalfunctionAug 12, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE INNER CANNULA WAS CRACKED ON THE SECOND CLEANING. THE PATIENT WAS DECANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 15218533 ↗

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