Shiley 10IC10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521511910), received between Dec 5, 2020 and Dec 5, 2020 — classified as 1 malfunction.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS ISSUE ON THE LENGTH OF THE INNER CANULA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950358 ↗

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