Shiley 5IC70Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521511965), received between Mar 12, 2025 and Apr 19, 2025 — classified as 5 malfunctions.

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

• MalfunctionApr 19, 2025Crack; Crack

  IT WAS REPORTED THAT DURING THE INNER CANNULA REPLACEMENT, THE CANNULA HAD A CRACK WHEN PULLED OUT. THE INNER CANNULA WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869765 ↗
• MalfunctionMar 25, 2025Component Missing; Material Split, Cut or Torn; Component Missing; Material Split, Cut or Torn

  IT WAS REPORTED THAT ONE OF THE CANNULAS OF THE TRACHEOSTOMY TUBE WAS OUT THE PACKAGE OR NO PACKAGE AT ALL JUST SITTING INSIDE THE BOX. THE OTHER FOUR CANNULAS HAD CUTS AND OR MISSING PIECES OF PLASTIC ALMOST GOT STUCK IN THE TRACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690263 ↗
• MalfunctionMar 12, 2025Component Missing; Material Split, Cut or Torn; Component Missing; Material Split, Cut or Torn

  IT WAS REPORTED THAT ONE OF THE CANNULAS OF THE TRACHEOSTOMY TUBE WAS OUT THE PACKAGE OR NO PACKAGE AT ALL JUST SITTING INSIDE THE BOX. THE OTHER FOUR CANNULAS HAD CUTS AND OR MISSING PIECES OF PLASTIC ALMOST GOT STUCK IN THE TRACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586975 ↗
• MalfunctionMar 12, 2025Component Missing; Material Split, Cut or Torn; Component Missing; Material Split, Cut or Torn

  IT WAS REPORTED THAT ONE OF THE CANNULAS OF THE TRACHEOSTOMY TUBE WAS OUT THE PACKAGE OR NO PACKAGE AT ALL JUST SITTING INSIDE THE BOX. THE OTHER FOUR CANNULAS HAD CUTS AND OR MISSING PIECES OF PLASTIC ALMOST GOT STUCK IN THE TRACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586966 ↗
• MalfunctionMar 12, 2025Component Missing; Material Split, Cut or Torn; Component Missing; Material Split, Cut or Torn

  IT WAS REPORTED THAT ONE OF THE CANNULAS OF THE TRACHEOSTOMY TUBE WAS OUT THE PACKAGE OR NO PACKAGE AT ALL JUST SITTING INSIDE THE BOX. THE OTHER FOUR CANNULAS HAD CUTS AND OR MISSING PIECES OF PLASTIC ALMOST GOT STUCK IN THE TRACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586904 ↗

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