Shiley 18870 (UDI 40884521032522)Recalls & reported problems

Summary

The FDA's MAUDE database contains 202 adverse event reports that list this exact device (DI 40884521032522), received between Jun 20, 2017 and Aug 25, 2026 — classified as 1 death, 47 injuries, 154 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (95 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 202 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436692 ↗
• InjuryJun 19, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER SURGERY PATIENT WAS INTUBATED DUE TO POOR OXYGENATION. AFTER SIX HOURS, PATIENT'S OXYGENATION HAD DECREASE AND DISCOVERED THAT THE ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAK. AFTER A CHEST X-RAY EVALUATION, THE MEDICAL STAFF IMMEDIATELY REPLACED THE ENDOTRACHEAL TUBE AND PERFORMED RE-INTUBATION.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 25561207 ↗
• MalfunctionJun 18, 2026Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD A CUFF AIR LEAK IDENTIFIED DURING A PRE-USE TEST IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25550085 ↗
• MalfunctionJun 4, 2026Gas/Air Leak; Failure to Seal

  IT WAS REPORTED THAT DURING USE, THERE WAS POOR SEALING OF THE ENDOTRACHEAL TUBE CUFF WAS NOTED, WITH OBVIOUS CUFF AIR LEAKAGE AND A SIGNIFICANT INCREASE IN VENTILATOR LEAK VOLUME. THE ENDOTRACHEAL TUBE WAS THEN REPLACED. THE PROCEDURE WAS SMOOTH, WITH NO ADVERSE EVENTS SUCH AS AIRWAY OBSTRUCTION FROM SPUTUM OR ASPHYXIA, AND THE PATIENT¿S OXYGENATION STATUS WAS SUBSEQUENTLY MONITORED.

  Patient problems: Unintended Extubation

  MAUDE report 25396986 ↗
• MalfunctionJun 3, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER INTUBATION, IT WAS FOUND THAT THE ENDOTRACHEAL TUBE'S CUFF COULD NOT BE INFLATED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 25382001 ↗
• MalfunctionJun 3, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER INTUBATION, IT WAS FOUND THAT THE ENDOTRACHEAL TUBE'S CUFF COULD NOT BE INFLATED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 25380373 ↗
• InjuryJun 1, 2026Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THERE WAS A PRESENCE OF LEAK ON THE RESPIRATOR, CUFF TESTED BECAUSE IT DEFLATED, THE CUFF REINFLATED AGAIN USING THE PRESSURE GAUGE TO 30 CM H2O AND THE CUFF BURST (NOISE HEARD AT THIS TIME). THE PATIENT HAD SIGNIFICANT AND RAPID DESATURATION AT 50%. THE PATIENT HAD A RE-INTUBATION.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 25351626 ↗
• MalfunctionMay 5, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING INTUBATION, AIR LEAKAGE FROM THE ENDOTRACHEAL TUBE CUFF WAS IDENTIFIED. THE TUBE WAS IMMEDIATELY REPLACED WITH A NEW ONE PROMPTLY, AND TREATMENT CONTINUED. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 25083881 ↗
• MalfunctionApr 22, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE COULD NOT BE SECURED DURING INTUBATION. AIR LEAKAGE FROM THE CUFF WAS IDENTIFIED, AND THE TUBE WAS REMOVED AND REPLACED WITH A NEW ENDOTRACHEAL TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 24952944 ↗
• MalfunctionApr 15, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD AN AIR LEAK. ENDOTRACHEAL TUBE WAS IMMEDIATELY REPLACED, AFTER WHICH VENTILATION FUNCTIONED NORMALLY.

  Patient problems: Unintended Extubation

  MAUDE report 24891891 ↗
• MalfunctionApr 7, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE VENTILATOR ALARMED FREQUENTLY AND INDICATED AIR LEAKAGE. DESPITE MULTIPLE ATTEMPTS TO INFLATE THE CUFF, A CUFF LEAK IN THE ENDOTRACHEAL TUBE WAS IDENTIFIED. THE ENDOTRACHEAL TUBE WAS IMMEDIATELY REPLACED WITH A NEW ONE, AFTER WHICH THE VENTILATOR FUNCTIONED NORMALLY.

  Patient problems: Unintended Extubation

  MAUDE report 24801324 ↗
• 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 24634212 ↗
• MalfunctionFeb 26, 2026Disconnection

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE ENDOTRACHEAL TUBE'S 15MM CONNECTOR WAS PRONE TO COMING OFF, AS SHOWN IN THE ATTACHED IMAGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24454212 ↗
• MalfunctionFeb 20, 2026Use of Device Problem

  IT WAS REPORTED THAT AFTER A SUCCESSFUL SURGERY, THE BALLOON OF THE ENDOTRACHEAL TUBE HAD SUDDENLY DETACHED. THE ENDOTRACHEAL TUBE WAS NOT IMMEDIATELY REPLACED, INSTEAD AN ADHESIVE WAS APPLIED TO THE DAMAGED AREA. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24399699 ↗
• MalfunctionFeb 18, 2026Use of Device Problem

  IT WAS REPORTED THAT THE INFLATABLE CUFF WAS DETACHED POST-OPERATIVELY. THE PATIENT WAS IN CRITICAL CONDITION, SO TUBE REPLACEMENT WAS TEMPORARILY NOT PERFORMED BUT NOT CAUSED BY THE DEVICE ISSUE. THE DAMAGED AREA WAS TREATED WITH ADHESIVE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24384523 ↗
• InjuryFeb 6, 2026Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT TO PROTECT THE AIRWAY, ENDOTRACHEAL INTUBATION WAS PERFORMED IN THE EMERGENCY ROOM, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WITH A MANUAL RESUSCITATOR. UPON ADMISSION, THE PATIENT HAD AN OROTRACHEAL TUBE IN PLACE. AFTER CONNECTING TO THE VENTILATOR, A LOW TIDAL VOLUME ALARM WAS TRIGGERED. EXAMINATION REVEALED THAT THE ENDOTRACHEAL TUBE CUFF WAS DAMAGED. THE ENDOTRACHEAL TUBE WAS THEN REPLACED. VENTILATOR-ASSISTED BREATHING WAS CONTINUED, AND THE PATIENT'S CONDITION IMPROVED.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 24282685 ↗
• MalfunctionJan 14, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USE TESTING OF THE ENDOTRACHEAL TUBE, A CUFF AIR LEAK WAS DETECTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073027 ↗
• MalfunctionJan 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING TESTING/MAINTENANCE, PARAMEDIC WAS PRACTICING WORKING WITH THE VENTILATOR ON A MANNEQUIN. THE MANNEQUIN WAS INTUBATED WITH A 7.0 ENDOTRACHEAL TUBE, THE TUBE'S CUFF SUDDENLY POPPED INSIDE THE MANNEQUIN. NO OBVIOUS EXPLANATION WAS NOTED INSIDE THE MANNEQUIN'S AIRWAY (I.E. NO FOREIGN OBJECTS OR SIMILAR) WERE NOTED UPON INSPECTION EITHER PRE OR POST TUBE PLACEMENT. ENDOTRACHEAL TUBE WAS INFLATED WITH THE PROPER AMOUNT OF AIR IN THE CUFF AND WAS BRAND NEW OUT OF THE PACKAGE. ENDOTRACHEAL TUBE WAS USED APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020195 ↗
• 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 23981059 ↗
• 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 23971265 ↗
• 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 23970472 ↗
• 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 23969332 ↗
• 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 23956564 ↗
• InjuryDec 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE VENTILATOR REPEATEDLY ALARMED DUE TO INSUFFICIENT TIDAL VOLUME VENTILATION. UPON INSPECTION, IT WAS FOUND T HAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD "RUPTURED". AFTER REPLACING THE ENDOTRACHEAL TUBE, INSUFFICIENT TIDAL VOLUME VENTILATION DID NOT OCCUR AGAIN.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 23782996 ↗
• MalfunctionDec 4, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE CUFFS OF THE SEVEN ENDOTRACHEAL TUBES HAD POOR SEALING PRIOR TO USE. DURING THE TEST, THE CUFF PRESSURE WAS MAINTAINED AT 25-30 CMH2O, BUT LIQUID LEAKAGE WAS STILL OBSERVED AT THE TOP OF THE CUFF, INDICATING POOR CUFF SEAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724096 ↗