Shiley 18885 (UDI 40884521032553)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 40884521032553), received between Jan 24, 2019 and Aug 11, 2026 — classified as 11 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (12 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216088 ↗
• MalfunctionAug 11, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216034 ↗
• 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 23980951 ↗
• 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 23980941 ↗
• 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 23971145 ↗
• 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 23971028 ↗
• 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 23970435 ↗
• 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 23970390 ↗
• 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 23968541 ↗
• 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 23968536 ↗
• MalfunctionJan 5, 2026Disconnection

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S TOP ADAPTER WAS EASILY REMOVED FROM THE TUBE ITSELF AND THE ISSUE OCCURRED WHEN REMOVING THE STYLET. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 23956307 ↗
• 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 23956278 ↗
• MalfunctionFeb 7, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS AN AIR LEAKAGE ON THE CUFF. TUBE WAS REPLACED.

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

  MAUDE report 21336463 ↗
• MalfunctionJan 22, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF ON AN 8.5MM ENDOTRACHEAL TUBE DEFLATED, CAUSING AN AIRWAY LEAK. NO ADDITIONAL DETAILS REGARDING PATIENT SYMPTOMS, COMPLICATIONS, OR OUTCOMES WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21206704 ↗
• MalfunctionMay 17, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT BALLOON AND CUFF LEAKED DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19347065 ↗
• MalfunctionMay 17, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT BALLOON AND CUFF LEAKED DURING USE. THE TUBE WAS REPLACED THE NEXT DAY.

  Patient problems: Unintended Extubation

  MAUDE report 19347002 ↗
• MalfunctionMar 6, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT BALLOON AND CUFF LEAKED DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 18852436 ↗
• MalfunctionJan 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF TEAR OCCURRED AROUND 20 DAYS SINCE INTUBATION. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18518498 ↗
• 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 17773995 ↗
• InjurySep 16, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT IN THE SURGICAL INTENSIVE CARE UNIT HAD BEEN INTUBATED FOR LESS THAN 24 HOURS (SEDATED AND PARALYZED). THE LEAKS WAS OBSERVED AT LEVEL OF THE BALLOON WHICH WAS THEN "POROUS". THE PATIENT WAS IN RESPIRATORY DISTRESS AND HAD TO BE REINTUBATED AFTER A FEW HOURS WITH ANOTHER DEVICE WHICH DID NOT PRESENT ANY PARTICULAR CONCERNS.

  Patient problems: Respiratory Insufficiency; Unintended Extubation

  MAUDE report 15441018 ↗
• InjurySep 16, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT IN THE SURGICAL INTENSIVE CARE UNIT HAD BEEN INTUBATED FOR LESS THAN 24 HOURS (SEDATED AND PARALYZED). THE LEAKS WAS OBSERVED AT LEVEL OF THE BALLOON WHICH WAS THEN "POROUS". THE PATIENT WAS IN RESPIRATORY DISTRESS AND HAD TO BE REINTUBATED AFTER A FEW HOURS WITH ANOTHER DEVICE WHICH DID NOT PRESENT ANY PARTICULAR CONCERNS.

  Patient problems: Respiratory Insufficiency; Unintended Extubation

  MAUDE report 15440871 ↗
• MalfunctionApr 13, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14108584 ↗
• MalfunctionJan 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE HAD DAMAGE. THERE WAS NO PATIENT HARM.

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

  MAUDE report 13307094 ↗
• MalfunctionNov 16, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD AN INFLATION/DEFLATION ISSUE. REINTUBATION WAS PERFORMED.

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

  MAUDE report 12819804 ↗
• MalfunctionNov 1, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AN 8.5 MM WAS SELECTED AND USED TO KEEP THE LUMEN WIDE. THERE WAS NO PROBLEM DURING THE PRE-USAGE CUFF CHECKING, NO PROTRUSION SUCH AS CARTILAGE WAS FOUND IN THE AREA AROUND THE TRACHEA IN THE CT IMAGES. THERE WERE A LOT OF SECRETION AND COUGH ATTACKS THAT OCCURRED EVERY TIME SUCTION WAS PERFORMED. AT THAT TIME, THE TRACHEAL TUBE WAS MOVING DUE TO THE "PLAY" (BUFFER, LOOSE, SPACE) OF THE CUFF. WHEN THE CUFF WAS SUBMERGED IN WATER, THE SAME LOCATION AROUND THE UPPER SUCTION HOLE OF THE CUFF WAS DAMAGED. THE PATIENT WAS REPEATEDLY INTUBATED, WHICH RESULTED IN A LOW-PRESSURE ALARM, VENTILATION FAILURE, STRESS DUE TO REINTUBATION AND ASPIRATION.

  Patient problems: Aspiration/Inhalation; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 12727718 ↗