Shiley 7UN80ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521175737), received between May 21, 2019 and Nov 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD A PAIN COMPLAINT IN THE TRACHEA. THE TRACHEOSTOMY TUBE'S CANNULA WAS FOUND LONGER THAN THE TUBE.

  Patient problems: Pain

  MAUDE report 20642055 ↗
• InjuryMay 21, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE UNIT HAD A DIMENSIONAL ISSUE. IT WAS INDICATED THAT PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 8629532 ↗