Shiley 87435Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521816282), received between Oct 17, 2024 and Jun 4, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 10 most recent of 10 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 25399599 ↗
• MalfunctionJul 16, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PRE-TEST, THE ENDOTRACHEAL TUBE'S CUFF WAS HERNIATED, AS SHOWN IN THE IMAGE ATTACHED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521812 ↗
• MalfunctionJun 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT INFLATE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136067 ↗
• MalfunctionApr 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE ENDOTRACH TUBE'S CONNECTOR PART OF THE TUBE WAS BROKEN FROM THE BASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890748 ↗
• MalfunctionOct 23, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE ARE SOME ENDOTRACHEAL TUBE'S CUFF THAT HAD OBSERVED BLOWING UP WHEN TESTED WITH PRESSURE. SOME CUFF ARE UNEVEN WHEN FILLED UP WITH AIR AND THERE ARE SOME PRODUCING BUBBLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20518153 ↗
• MalfunctionOct 23, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE ARE SOME ENDOTRACHEAL TUBE'S CUFF THAT HAD OBSERVED BLOWING UP WHEN TESTED WITH PRESSURE. SOME CUFF ARE UNEVEN WHEN FILLED UP WITH AIR AND THERE ARE SOME PRODUCING BUBBLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20518147 ↗
• MalfunctionOct 23, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE ARE SOME ENDOTRACHEAL TUBE'S CUFF THAT HAD OBSERVED BLOWING UP WHEN TESTED WITH PRESSURE. SOME CUFF ARE UNEVEN WHEN FILLED UP WITH AIR AND THERE ARE SOME PRODUCING BUBBLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517851 ↗
• MalfunctionOct 17, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE ARE SOME ENDOTRACHEAL TUBE'S CUFF THAT HAD OBSERVED BLOWING UP WHEN TESTED WITH PRESSURE. SOME CUFF ARE UNEVEN WHEN FILLED UP WITH AIR AND THERE ARE SOME PRODUCING BUBBLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471433 ↗
• MalfunctionOct 17, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE ARE SOME ENDOTRACHEAL TUBE'S CUFF THAT HAD OBSERVED BLOWING UP WHEN TESTED WITH PRESSURE. SOME CUFF ARE UNEVEN WHEN FILLED UP WITH AIR AND THERE ARE SOME PRODUCING BUBBLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471344 ↗
• MalfunctionOct 17, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE ARE SOME ENDOTRACHEAL TUBE'S CUFF THAT HAD OBSERVED BLOWING UP WHEN TESTED WITH PRESSURE. SOME CUFF ARE UNEVEN WHEN FILLED UP WITH AIR AND THERE ARE SOME PRODUCING BUBBLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471323 ↗