Shiley 18765Recalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 10884522007580), received between Jan 8, 2019 and Sep 11, 2026 — classified as 6 injuries, 135 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (108 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Use of Device Problem

  It was reported that during the pre-usage inspection, the endotracheal tube's cuff had an inflation or deflation issue. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726460 ↗
• MalfunctionJul 15, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF DID NOT INFLATE, AIR LEAKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25828401 ↗
• MalfunctionJun 18, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE INFLATION WAS EXCESSIVELY SLOW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546595 ↗
• MalfunctionFeb 26, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-TESTING, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455515 ↗
• MalfunctionFeb 9, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT POST-OPERATIVELY, THE TIP OF THE ENDOTRACHEAL TUBE WAS FOUND SPLIT, AS SHOWN IN THE ATTACHED IMAGE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24292741 ↗
• MalfunctionJan 20, 2026Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAK. THE TUBE WAS REPLACED.

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

  MAUDE report 24115940 ↗
• InjuryDec 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF BURST WHEN THE DOCTOR WAS INTUBATING. THE EVENT OCCURRED IN A HOSPITAL SETTING. THE PATIENT EXPERIENCED POSTOPERATIVE NECROTIC TISSUE AND THE TUBE WAS REPLACED.

  Patient problems: Necrosis; Unintended Extubation

  MAUDE report 23832154 ↗
• InjuryDec 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF BURST WHEN THE DOCTOR WAS INTUBATING. THE PATIENT EXPERIENCED NECROTIC TISSUE AND THE TUBE WAS REPLACED.

  Patient problems: Necrosis; Unintended Extubation

  MAUDE report 23824673 ↗
• MalfunctionDec 8, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE EXPERIENCED A CUFF INFLATION AND DEFLATION ISSUE PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751681 ↗
• MalfunctionDec 2, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, TWO ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUES EACH. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694121 ↗
• MalfunctionDec 2, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, TWO ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUES EACH. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694005 ↗
• MalfunctionNov 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS DIFFICULT TO INFLATE AND ALSO DOESN'T DEFLATE WELL PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592972 ↗
• MalfunctionNov 6, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486933 ↗
• MalfunctionNov 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USE TESTING, THE SIZE OF THE INFLATION OF THE ENDOTRACHEAL TUBE'S CUFF AND THE INFLATION OF THE BALLOON WERE DIFFERENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464826 ↗
• MalfunctionOct 31, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE CUFF HAD A RAPID DROP IN PRESSURE SOON AFTER INFLATION DURING PRE-TEST, AT THE HOSPITAL. THE TUBE WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441713 ↗
• MalfunctionSep 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PRESSURE OF THE CUFF ON THE ENDOTRACHEAL TUBE COULD NOT BE MAINTAINED OVER 20 MMHG PRIOR TO USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983234 ↗
• MalfunctionAug 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, BOTH ENDOTRACHEAL TUBE'S CUFF HAD A LEAKS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874458 ↗
• MalfunctionAug 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, BOTH ENDOTRACHEAL TUBE'S CUFF HAD A LEAKS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874420 ↗
• MalfunctionAug 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD POOR INFLATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846321 ↗
• MalfunctionAug 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT BALLOONING DID NOT WORK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22692876 ↗
• MalfunctionJul 29, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CUFF LEAKS WAS IDENTIFIED WITH THE TWO ENDOTRACHEAL TUBES IN A HOSPITAL SETTING. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22660122 ↗
• MalfunctionJul 29, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CUFF LEAKS WAS IDENTIFIED WITH THE TWO ENDOTRACHEAL TUBES IN A HOSPITAL SETTING. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22660054 ↗
• MalfunctionJul 23, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD AN AIR LEAK, AT A HOSPITAL. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22580128 ↗
• MalfunctionJul 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD INFLATION AND DEFLATION ISSUES PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572707 ↗
• MalfunctionJul 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUE BEFORE USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22570399 ↗