Shiley 18880 (UDI 40884521032546)Recalls & reported problems

Summary

The FDA's MAUDE database contains 370 adverse event reports that list this exact device (DI 40884521032546), received between Oct 17, 2017 and Jul 3, 2026 — classified as 2 deaths, 105 injuries, 263 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (149 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 370 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2026Use of Device Problem

  IT WAS REPORTED THAT AN ENDOTRACHEAL TUBE WAS EVALUATED DURING PRE-INTUBATION TESTING AND THE CUFF WAS VERY DIFFICULT TO INFLATE AND IMPOSSIBLE TO DEFLATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702652 ↗
• MalfunctionJun 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE INTUBATION OF THE PATIENT, THERE WAS BACKGROUND NOISE AT THE TUBE, LEAKAGE AT THE RESPIRATOR. AS A RESULT, EXTUBATION AND RE-INTUBATION WERE NECESSARY. THE PATIENT'S SATURATION WAS STABLE AT ALL TIMES, NOT A CRITICAL SITUATION. WHEN THE TUBE WAS INSPECTED, A HOLE OF APPROX 0.5MM X 0.5MM COULD BE SEEN AT THE LEVEL OF THE CONNECTION POINT OF THE SUBGLOTTIC SUCTION.

  Patient problems: Unintended Extubation

  MAUDE report 25365547 ↗
• MalfunctionJun 1, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE OF A ENDOTRACHEAL TUBE, AN ATTEMPT WAS MADE TO INFLATE THE CUFF WITH NO SUCCESS. THE PATIENT HAD TO BE RE-INTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 25352209 ↗
• InjuryMay 28, 2026Crack; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT REQUIRED IMMEDIATE INTUBATION DUE TO RESPIRATORY DISTRESS. THE 1ST ENDOTRACHEAL TUBE HAD A LARGE CUFF LEAK AND A CRACKED TUBE. THE 2ND TUBE HAD THE SAME ISSUE AND REQUIRED 3RD ATTEMPT.

  Patient problems: Respiratory Insufficiency; Unintended Extubation

  MAUDE report 25320552 ↗
• InjuryMay 28, 2026Crack; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT REQUIRED IMMEDIATE INTUBATION DUE TO RESPIRATORY DISTRESS. THE 1ST ENDOTRACHEAL TUBE HAD A LARGE CUFF LEAK AND A CRACKED TUBE. THE 2ND TUBE HAD THE SAME ISSUE AND REQUIRED 3RD ATTEMPT.

  Patient problems: Respiratory Insufficiency; Unintended Extubation

  MAUDE report 25320481 ↗
• InjuryApr 24, 2026Disconnection

  IT WAS REPORTED THAT DURING OROTRACHEAL INTUBATION, THE CONNECTOR BETWEEN THE ENDOTRACHEAL TUBE AND THE ARTIFICIAL MANUAL BREATHING UNIT (AMBU) BAG WAS DISCONNECTED, AND THE PATIENT SUFFERED CARDIAC ARREST. THE TUBE WAS REPLACED.

  Patient problems: Cardiac Arrest; Unintended Extubation

  MAUDE report 24983280 ↗
• MalfunctionMar 30, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A PRE-USE INSPECTION OF THE ENDOTRACHEAL TUBE, CUFF LEAKAGE WAS IDENTIFIED AND THE CUFF COULD NOT BE INFLATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737045 ↗
• MalfunctionMar 30, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A PRE-USE INSPECTION OF THE ENDOTRACHEAL TUBE, CUFF LEAKAGE WAS IDENTIFIED AND THE CUFF COULD NOT BE INFLATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736967 ↗
• MalfunctionMar 30, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE FOUR ENDOTRACHEAL TUBES HAD A SMALL LEAK DURING USE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24716546 ↗
• MalfunctionMar 30, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE FOUR ENDOTRACHEAL TUBES HAD A SMALL LEAK DURING USE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24716533 ↗
• MalfunctionMar 30, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE FOUR ENDOTRACHEAL TUBES HAD A SMALL LEAK DURING USE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24716520 ↗
• MalfunctionMar 30, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE FOUR ENDOTRACHEAL TUBES HAD A SMALL LEAK DURING USE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24716480 ↗
• MalfunctionMar 18, 2026Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629378 ↗
• MalfunctionMar 18, 2026Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629359 ↗
• MalfunctionMar 18, 2026Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626095 ↗
• MalfunctionFeb 27, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A PLANNED ENDOTRACHEAL TUBE CHANGE ON CRITICAL CARE, THE ENDOTRACHEAL TUBE EXPERIENCED ISSUES WITH THE CUFF. SPECIFICALLY, THERE WAS RESISTANCE FELT DURING CUFF INFLATION, AND THE CUFF WOULD NOT DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477348 ↗
• MalfunctionFeb 27, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A PLANNED ENDOTRACHEAL TUBE CHANGE ON CRITICAL CARE, THE ENDOTRACHEAL TUBE EXPERIENCED ISSUES WITH THE CUFF. SPECIFICALLY, THERE WAS RESISTANCE FELT DURING CUFF INFLATION, AND THE CUFF WOULD NOT DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476691 ↗
• MalfunctionFeb 27, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A PLANNED ENDOTRACHEAL TUBE CHANGE ON CRITICAL CARE, THE ENDOTRACHEAL TUBE EXPERIENCED ISSUES WITH THE CUFF. SPECIFICALLY, THERE WAS RESISTANCE FELT DURING CUFF INFLATION, AND THE CUFF WOULD NOT DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476664 ↗
• MalfunctionFeb 27, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A PLANNED ENDOTRACHEAL TUBE CHANGE ON CRITICAL CARE, THE ENDOTRACHEAL TUBE EXPERIENCED ISSUES WITH THE CUFF. SPECIFICALLY, THERE WAS RESISTANCE FELT DURING CUFF INFLATION, AND THE CUFF WOULD NOT DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476563 ↗
• MalfunctionFeb 12, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A PATIENT¿S INTUBATION, THE ENDOTRACHEAL TUBE CRACKED AT THE CONNECTOR OF THE TUBE. THE PATIENT WAS REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 24325018 ↗
• InjuryFeb 2, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DECREASE IN HEART RATE AND OXYGEN SATURATION, UNSTABLE BLOOD PRESSURE, AND WEAKENED PULSATION OF THE MAJOR ARTERIES UPON PALPATION. IMMEDIATE CARDIOPULMONARY RESUSCITATION (CPR) AND EMERGENCY BEDSIDE ENDOTRACHEAL INTUBATION WERE PERFORMED. AFTER INTUBATION, A AIR LEAK AIR WAS DISCOVERED, AND THE PATIENT'S OXYGENATION DID NOT IMPROVE. A NOTICEABLE LEAKING SOUND WAS HEARD, AND THE CUFF COULD NOT BE INFLATED. THE TUBE WAS REPLACED WITH 7.5MM TUBE THAT FUNCTIONED NORMALLY BUT INCREASED DISCOMFORT FOR THE PATIENT.

  Patient problems: Discomfort; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 24242474 ↗
• MalfunctionJan 14, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE OF THE ENDOTRACHEAL TUBE, THE CUFF DID NOT INFLATE PROPERLY, RESULTING IN LEAKAGE DURING VENTILATION. THE EVENT OCCURRED IN A HOSPITAL SETTING AND THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24072806 ↗
• 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 23980958 ↗
• MalfunctionJan 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING SURGERY, TWO ENDOTRACHEAL TUBES WERE PLACED IN A PATIENT AND BOTH CUFFS EXHIBITED A SEVERE LEAK. THIS ISSUE NECESSITATED MULTIPLE TUBE EXCHANGES INTRAOPERATIVELY, THE USE OF HIGH VENTILATOR SETTINGS, AND ADMINISTRATION OF NITRIC OXIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 23977579 ↗
• MalfunctionJan 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING SURGERY, TWO ENDOTRACHEAL TUBES WERE PLACED IN A PATIENT AND BOTH CUFFS EXHIBITED A SEVERE LEAK. THIS ISSUE NECESSITATED MULTIPLE TUBE EXCHANGES INTRAOPERATIVELY, THE USE OF HIGH VENTILATOR SETTINGS, AND ADMINISTRATION OF NITRIC OXIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 23977444 ↗