Shiley 7UN80HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521176260), received between Dec 20, 2019 and Nov 6, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY WAS BREAKING AROUND THE TOP WHERE THE INNER CANNULA GOES IN. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20620732 ↗
• MalfunctionNov 5, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE WAS BREAKING AROUND THE TOP WHERE THE INNER CANNULA GOES IN. THE PATIENT'S NECK WAS IRRITATED AROUND THAT AREA DUE TO IT BEING BROKEN. THE TRACH TUBE WAS REPLACED.

  Patient problems: Inflammation

  MAUDE report 20611286 ↗
• MalfunctionNov 5, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE WAS BREAKING AROUND THE TOP WHERE THE INNER CANNULA GOES IN. THE PATIENT'S NECK WAS IRRITATED AROUND THAT AREA DUE TO IT BEING BROKEN. THE TRACH TUBE WAS REPLACED.

  Patient problems: Inflammation

  MAUDE report 20611239 ↗
• MalfunctionMar 10, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF LEAKAGE. THE TUBE WAS REPLACED SUCCESSFULLY. ANOTHER CUFF LEAKAGE OCCURRED AND THE PATIENT HAD A REPLACEMENT OF THE TUBE FOR THE SECOND TIME.

  Patient problems: Unintended Extubation

  MAUDE report 13721437 ↗
• InjuryDec 20, 2019Use of Device Problem; Component Missing; Use of Device Problem; Component Missing

  ACCORDING TO THE REPORTER, TRACH CUFF BALLOON WILL NOT HOLD AIR. PATIENT REQUIRED REMOVAL OF EXISTING TRACHEOSTOMY AND REPLACEMENT AT BEDSIDE. THEY REMOVED ATTEMPTED TO REPLACE TRACHEOSTOMY USING BEDSIDE EMERGENCY TRACH FROM EMERGENCY TRACH SUPPLIES. AFTER REMOVING PREVIOUS TRACH AND OPENING NEW TRACH FROM SUPPLIES, NOTED TO HAVE WRONG TRACH. EXISTING TRACH HAD CUFF, AVAILABLE REPLACEMENT TRACH HAD NO CUFF. PATIENT REQUIRED RE-INTUBATION AT BEDSIDE. BOTH TRACHS WERE CORRECT SIZE AND "NAVY" COLOR, ONE HAVING A CUFF AND THE OTHER NONE.

  Patient problems: Extubate

  MAUDE report 9502106 ↗