Shiley 8UN85RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521205529), received between Oct 21, 2022 and Sep 19, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER USING THE TRACHEOSTOMY TUBE'S INNER CANNULA, IT WAS FOUND THAT THERE WAS AN OPENING WHERE AIR PASSES MAKING SPEECH IMPOSSIBLE, AS SHOWN IN THE ATTACHED PHOTO. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258363 ↗
• MalfunctionJul 5, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN ISSUE WITH THE DESIGN OF THE TUBE; THE SPLIT INNER CANNULA DESIGN WOULD NOT ALLOW THE PATIENT TO TALK AND PROHIBITED THE PATIENT FROM DOING THE DAY-TO-DAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684257 ↗
• InjuryJun 25, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SIZE IN THE BOX OF THE FIRST DEVICE WAS INCORRECT. THE PATIENT USED A CALIPER TO CHECK THE SIZE AND FOUND THAT THE SIZES LISTED ON THE BOX WERE INCORRECT. THE PATIENT MENTIONED THAT IT WAS MUCH SMALLER THAN THE PREVIOUS VERSION, AND THE INNER AND OUTER DIAMETERS WERE NOT THE SAME. THE PATIENT AIRWAY WAS RESTRICTED AND NOISY. THE PATIENT WENT UP TO A 9-MM TUBE, WHICH WAS CLOSER TO THE SIZE OF THE FIRST DEVICE, BUT STILL FELT MORE NARROWED, WHICH CAUSED ADDED NOISE AND VOLUME RESTRICTION, AND PREFERRED TO HAVE THE OLD STYLE BACK.

  Patient problems: Airway Obstruction; Discomfort; Unintended Extubation

  MAUDE report 19607545 ↗
• MalfunctionJun 25, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TUBE DID NOT FIT LIKE THE OLD DEVICE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19607429 ↗
• MalfunctionDec 19, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE WAS SPLIT IN LENGTHWISE BASED ON THE PHOTO PROVIDED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18356561 ↗
• MalfunctionOct 21, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT HAD A COMPLAINT OF THE TRACH REPLACEMENT. IT WAS SAID THAT THE TRACH SIZE WAS INCORRECT, IT WAS TOO LONG FROM THE OLD TRACH. PATIENT HAD A DISCOMFORT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655109 ↗

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