Shiley 18860Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 40884521032492), received between Jan 9, 2020 and Jan 6, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 23980846 ↗
• 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 23971284 ↗
• 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 23970505 ↗
• 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 23968483 ↗
• 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 23956671 ↗
• MalfunctionDec 4, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE THE PHYSICIAN INTUBATED THE PATIENT SUCCESSFULLY, BUT THE ENDOTRACHEAL TUBE'S CUFF WAS FOUND TO BE BROKEN. THE PATIENT WAS EXTUBATED THEN REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 23723328 ↗
• MalfunctionJun 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF WAS LEAKING DURING USE. THE RN REPOSITIONED THE PATIENT'S HEAD IN ATTEMPT TO RESOLVE LEAK WITH NO EFFECT, THEN ASSESSED THE TUBE WHICH WAS FOUND TO HAVE MIGRATED SIGNIFICANTLY. FINAL 19 CM MARKER OF THE TUBE NOTED TO BE PROTRUDING MANY CM PAST PATIENT¿S TEETH. THE RN TOOK MANUAL CONTROL OF TUBE. THE RT APPROACHED BEDSIDE TO ASSESS, ADVANCED THE TUBE TO 25 CM, AND STATED AIRWAY WAS CURRENTLY SAFE BUT REQUIRED URGENT ASSESSMENT. THE INTENSIVIST ARRIVED AND REQUESTED BRONCHOSCOPY EQUIPMENT, AND THAT THE PATIENT NOT BE MOVED UNTIL DETERMINATION OF SAFETY MADE. AN EMERGENT BRONCHOSCOPY PERFORMED ON CT TABLE, WITH TUBE DETERMINED TO REMAIN AT INADEQUATE DEPTH. THE TUBE WAS ADVANCED UNDER SUPERVISION OF ICU INTENSIVIST TO APPROPRIATE DEPTH AND WAS SECURED BY THE RRT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289863 ↗
• MalfunctionJun 6, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22160023 ↗
• MalfunctionMar 1, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THERE WERE SEVERAL INSTANCES WHEN THE 15-MM CONNECTORS OF THE ENDOTRACHEAL TUBES "POPPED OFF" DURING CODES AND AFTER INTUBATION. THERE WERE TIMES WHERE THE CONNECTOR CAME OFF WITH THE AMBU BAG AFTER BAGGING A PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18817752 ↗
• MalfunctionJun 30, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS A LEAK HEARD FROM THE ENDOTRACHEAL TUBE. ATTEMPTED TO ADD AIR TO THE CUFF AND FAILED TO HOLD AIR. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17238319 ↗
• MalfunctionJul 26, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACH CUFF DID NOT INFLATE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103806 ↗
• InjurySep 3, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER INTUBATION, THEY TRIED TO INJECT AIR INTO THE CUFF, BUT AIR WAS DIFFICULT TO GO IN. NO CUFF CHECK WAS PERFORMED BEFORE INTUBATION. IT WAS USED ON A PATIENT WHO WAS SUSPECTED TO BE CORONA POSITIVE.

  Patient problems: Extubate

  MAUDE report 10487034 ↗
• InjuryJan 9, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD BALLOON RUPTURE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Extubate; No Patient Involvement

  MAUDE report 9569595 ↗