Shiley 87445Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521816305), received between Feb 10, 2026 and Jun 4, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, FOUR ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399712 ↗
• MalfunctionApr 29, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, FOLLOWING INTUBATION OF A PEDIATRIC PATIENT, A TEAR WAS NOTICED AT THE TUBE SEAM OF AN ENDOTRACHEAL TUBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 25037711 ↗
• MalfunctionFeb 10, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HAD A LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304477 ↗