Shiley 9IC90Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521511927), received between Feb 6, 2025 and Feb 10, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K142296); 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.

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.

• MalfunctionFeb 10, 2025Crack; Crack

  IT WAS REPORTED THAT NURSING STAFF NOTICED PHYSICAL DAMAGE TO A FLEXIBLE DISPOSABLE INNER CANNULA, WHICH HAD CRACKED ALONG THE DISTAL PART. ADDITIONALLY, IT WAS NOTED THAT THE CUSTOMER WAS REUSING THE DISPOSABLE INNER CANNULA FOR 24 HOURS UP TO 1 WEEK BY CLEANING IT WHEN NEEDED, DESPITE BEING INFORMED THAT THE CANNULA ARE INTENDED FOR SINGLE-USE ONLY. THE ISSUE TOOK PLACE IN A HOSPITAL SETTING. THE CUSTOMER HAD BEEN INFORMED OF THE SINGLE-USE NATURE OF THE CANNULA BUT CHOSE TO USE THEM OFF-LABEL ACCORDING TO THEIR OWN PROTOCOL. THE CRACKS WERE ESTIMATED TO HAVE APPEARED TWO DAYS AFTER THE CANNULA WERE TAKEN INTO USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351976 ↗
• MalfunctionFeb 6, 2025Crack; Human-Device Interface Problem; Crack; Human-Device Interface Problem

  IT WAS REPORTED THAT NURSING STAFF NOTICED PHYSICAL DAMAGE TO A FLEXIBLE DISPOSABLE INNER CANNULA, WHICH HAD A CRACKED ALONG THE DISTAL PART OF THE CANNULA. ADDITIONALLY, IT WAS NOTED THAT THE CUSTOMER WAS REUSING THE DISPOSABLE INNER CANNULA FOR 24 HOURS UP TO 1 WEEK BY CLEANING IT WHEN NEEDED, DESPITE BEING INFORMED THAT THE CANNULAS ARE INTENDED FOR SINGLE-USE ONLY. THE ISSUE TOOK PLACE INA HOSPITAL SETTING. THE CUSTOMER HAD BEEN INFORMED OF THE SINGLE-USE NATURE OF THE CANNULAS BUT CHOSE TO USE THEM OFF-LABEL ACCORDING TO THEIR OWN PROTOCOL. THE CRACKS WERE ESTIMATED TO HAVE APPEARED TWO DAYS AFTER THE CANNULAS WERE TAKEN INTO USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324510 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142296. One submission often covers many models, so check the product and lot details in each record.

• Z-1357-2023 · Mar 24, 2023 · Open, Classified
  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CU