Shiley 18865Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 40884521032515), received between Aug 14, 2017 and Jul 7, 2026 — classified as 11 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (16 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING INTUBATION PROCEDURE, THE ENDOTRACHEAL TUBE'S CUFF HAD POOR INFLATION AND AIR LEAKAGE WAS FOUND. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 25732478 ↗
• MalfunctionMay 15, 2026Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185613 ↗
• MalfunctionApr 11, 2026Gas/Air Leak; Failure to Seal

  IT WAS REPORTED THAT THE PILOT BALLOON OF THE ENDOTRACHEAL TUBE HAD LEAKS DURING USE. THERE WAS PROBLEMS MAINTAINING CUFF PRESSURE, REQUIRING REPEATED RE-INFLATION, SOMETIMES EVERY 10 MINUTES, TO ENSURE A PROPER SEAL. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24847456 ↗
• MalfunctionMar 18, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634155 ↗
• InjuryFeb 20, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PILOT BALLOON OF THE ENDOTRACHEAL TUBE HAD SEVERAL LEAKS. THERE WAS PROBLEMS MAINTAINING CUFF PRESSURE, REQUIRING REPEATED RE-INFLATION, SOMETIMES EVERY 10 MINUTES, TO ENSURE A PROPER SEAL. THE PATIENT HAD RESPIRATORY ARREST, WITH SUSPECTED MUCUS PLUGGING AND BRONCHOASPIRATION. IN ADDITION, BALLOON MALFUNCTIONS MAKE IT DIFFICULT TO MAINTAIN ADEQUATE VENTILATORY PRESSURE AND POSE RISKS DUE TO REPEATED MANIPULATION OF THE TUBE.

  Patient problems: Aspiration/Inhalation; Hypoventilation; Respiratory Arrest; Respiratory Failure; Unintended Extubation

  MAUDE report 24399630 ↗
• InjuryJan 6, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM DISCONNECTED WHILE BEING ACTIVELY VENTILATED WITH AN AMBU BAG DUE TO SLIGHT REPOSITIONING OF THE AMBU DEVICE WHILE ATTACHED TO THE TUBE. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 23981087 ↗
• InjuryJan 6, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM DISCONNECTED WHILE BEING ACTIVELY VENTILATED WITH AN AMBU BAG DUE TO SLIGHT REPOSITIONING OF THE AMBU DEVICE WHILE ATTACHED TO THE TUBE. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 23981065 ↗
• InjuryJan 6, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM CONNECTOR DISCONNECTED WHILE THE PATIENT WAS BEING ACTIVELY VENTILATED WITH AN AMBU BAG AFTER THE AMBULANCE HIT A BUMP WHILE TRAVELING DOWN THE ROAD. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 23971283 ↗
• InjuryJan 6, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM CONNECTOR DISCONNECTED WHILE THE PATIENT WAS BEING ACTIVELY VENTILATED WITH AN AMBU BAG AFTER THE AMBULANCE HIT A BUMP WHILE TRAVELING DOWN THE ROAD. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 23971270 ↗
• InjuryJan 5, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM DISCONNECTED RIGHT AFTER THE INTUBATION PROCEDURE WAS PERFORMED AS THE STYLET WAS BEING REMOVED FROM THE TUBE. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 23970488 ↗
• InjuryJan 5, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM DISCONNECTED RIGHT AFTER THE INTUBATION PROCEDURE WAS PERFORMED AS THE STYLET WAS BEING REMOVED FROM THE TUBE. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 23970482 ↗
• MalfunctionJan 5, 2026Disconnection

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBES TOP ADAPTER CAN EASILY BE REMOVE FROM THE TUBE ITSELF WITH MINIMAL EFFORT WHILE STILL IN THE PACKAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969377 ↗
• MalfunctionJan 5, 2026Disconnection

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBES TOP ADAPTER CAN EASILY BE REMOVE FROM THE TUBE ITSELF WITH MINIMAL EFFORT WHILE STILL IN THE PACKAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969351 ↗
• InjuryJan 5, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM DISCONNECTED RIGHT AFTER THE INTUBATION PROCEDURE WAS PERFORMED AS THE STYLET WAS BEING REMOVED FROM THE TUBE. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 23956626 ↗
• MalfunctionJan 5, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM DISCONNECTED RIGHT AFTER THE INTUBATION PROCEDURE WAS PERFORMED AS THE STYLET WAS BEING REMOVED FROM THE TUBE. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 23956604 ↗
• MalfunctionAug 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, A TRACH AND TWO ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUES. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22707118 ↗
• MalfunctionAug 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, A TRACH AND TWO ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUES. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22706803 ↗
• InjuryFeb 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE TRACHEAL INTUBATION OF THE PATIENT, IT WAS FOUND THAT THE TUBE'S CUFF WAS LEAKING AND COULD NOT BE USED. THE DOCTOR URGENTLY REPLACED IT WITH THE NEW TRACHEAL TUBE FOR RESCUE. DURING THE EMERGENCY INTUBATION, THE INTUBATION TIME WAS DELAYED.

  Patient problems: Unintended Extubation

  MAUDE report 21410426 ↗
• MalfunctionDec 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A TRACHEAL TUBE EXPERIENCED A CONNECTOR BREAK AT THE TRACHEAL TUBE INTERFACE, INDICATING PHYSICAL DAMAGE. THE ISSUE OCCURRED WITHIN A HOSPITAL SETTING. NO PATIENT WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909932 ↗
• MalfunctionDec 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE SET WAS COMPLETELY BROKEN AND COULD NOT BE USED, SO IMMEDIATELY DISCARDED IT AND REPLACED IT WITH A NEW ONE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880635 ↗
• MalfunctionJun 11, 2024Obstruction of Flow; Gas/Air Leak; Obstruction of Flow; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING PATIENT USE, THE ENDOTRACHEAL TUBE'S CUFF HAD AN OBVIOUS AIR LEAKAGE. CHECKED THE CUFF INFLATION AGAIN AND FOUND THAT THE CUFF INFLATION WAS BLOCKED AND COULD NOT BE INFLATED. THEN, THE TUBE OF THE SAME MODEL AND SPECIFICATION WAS REPLACED, AND IT COULD BE USED NORMALLY AFTER REPLACEMENT.

  Patient problems: Unintended Extubation

  MAUDE report 19512997 ↗
• MalfunctionSep 19, 2023Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE CONNECTOR TUBE WAS LOOSE AND EASILY DETACHES FROM THE ENDOTRACHEAL TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773746 ↗
• MalfunctionApr 27, 2023Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THERE WAS A HOLE NEAR THE BOUNDARY BETWEEN THE TUBE AND THE CUFF UPPER SUCTION TUBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827716 ↗
• MalfunctionDec 1, 2020Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD AIR LEAKAGE WHICH OCCURRED DURING CUFF TESTING. WHEN SOAKED IN WATER AND VERIFIED, NO DAMAGE WAS FOUND ON THE CUFF ITSELF, AND IT WAS REPORTED THAT THE INFLATION LINE WAS DAMAGED. IT WAS REPORTED THAT THE LEAKAGE IS AROUND THE BASE OF THE TIP OF THE PILOT LINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10924663 ↗
• InjuryOct 31, 2020Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD MICRO LEAKS AND RUPTURED CUFF. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 10767203 ↗