Shiley 18875SRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884521726703), received between Nov 20, 2020 and Mar 16, 2026 — classified as 5 injuries, 44 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. 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, THE ENDOTRACHEAL TUBE HAD AN UNKNOWN FAILURE. A NEW TUBE WAS USED. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE INFLATION LINE TUBING WAS COLLAPSED INSIDE THE LUMEN OF THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607250 ↗
• MalfunctionFeb 20, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PILOT BALLOON OF THE ENDOTRACHEAL TUBE HAD SEVERAL LEAKS DURING USE. THERE WAS PROBLEMS MAINTAINING CUFF PRESSURE, REQUIRING REPEATED RE-INFLATION, SOMETIMES EVERY 10 MINUTES, TO ENSURE A PROPER SEAL. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24399646 ↗
• MalfunctionJan 9, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT INFLATE NORMALLY AFTER INTUBATION. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24027068 ↗
• MalfunctionSep 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025441 ↗
• MalfunctionSep 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THERE WAS A VOICE LEAKAGE FROM THE INTUBATED PATIENT, SO AIR WAS INJECTED FROM THE PILOT BALLOON, BUT THERE WAS A LEAK IN THE ENDOTRACHEAL TUBE'S CUFF. THE TUBE WAS REPLACED WITH A NEW ONE AFTER CONSULTATION WITH THE PHYSICIAN.

  Patient problems: Unintended Extubation

  MAUDE report 22962970 ↗
• MalfunctionAug 28, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT 10CMH2O OF CUFF PRESSURE WAS INSERTED, AFTER THAT, ANOTHER NURSE DID NOT NOTICE THAT THE CUFF ALREADY HAD AIR IN IT, AND AN ADDITIONAL 10CMH2O WAS INSERTED, A "RUPTURE" OR "PLOSIVE" SOUND WAS HEARD, THEN THE CUFF "RUPTURED". THE PATIENT WAS REINTUBATED AND THERE WAS NO AIRWAY DAMAGE.

  Patient problems: Unintended Extubation

  MAUDE report 22912945 ↗
• MalfunctionAug 15, 2025Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819775 ↗
• MalfunctionJun 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN AIR LEAK WAS CONFIRMED FROM THE ENDOTRACHEAL TUBE AROUND THE THIRD WEEK AFTER THE START OF USE OF THE TUBE. AFTER TUBE REMOVAL, IT WAS DISCOVERED THAT AIR WAS LEAKING FROM THE AREA NEAR THE BASE OF THE CUFF. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22181836 ↗
• MalfunctionJun 9, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S PILOT BALLOON WAS DETACHED WHILE IT WAS CONNECTED TO THE VENTILATOR DURING THE PROCEDURE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22170836 ↗
• MalfunctionMay 30, 2025Crack; Material Integrity Problem; Crack; Material Integrity Problem

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S 15MM JOINT CONNECTOR WAS "RUPTURED" AFTER INTUBATING TO A PATIENT. THE RUPTURED PART WAS CUT AND THE CONNECTOR WAS RECONNECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117038 ↗
• MalfunctionMay 16, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF LEAKAGE WAS CONFIRMED FROM ABOUT AFTER 30 MINUTES AFTER ORAL INTUBATION. WHEN THE PHYSICIAN CHECKED THE CUFF AT THE TIME OF EXTUBATION, IT WAS SAID THAT THERE WAS A PINHOLE/HOLE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22033041 ↗
• MalfunctionApr 30, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF LEAK WAS CONFIRMED WITHIN 1 DAY AFTER START OF USE. THERE WAS NO IMPROVEMENT IN LEAKAGE DESPITE THE ADDITION OF AIR INTO THE CUFF. THE EVENT OCCURRED IN A HOSPITAL. THE TUBE WAS REPLACED AND A HOLE WAS DISCOVERED FROM THE REMOVED TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 21938958 ↗
• MalfunctionApr 29, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER TWO DAYS OF PATIENT USE, THE ENDOTRACHEAL TUBE'S CUFF HAD A LEAK AND AIR WAS ADDED, BUT THERE WAS NO IMPROVEMENT AND THE TUBE WAS REPLACED. WHEN LOOKED AT THE ONE THAT WAS REMOVED, IT WAS SAID THAT THERE WAS A HOLE IN THE CUFF.

  Patient problems: Unintended Extubation

  MAUDE report 21929291 ↗
• MalfunctionMar 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A DAMAGE AROUND THE TUBE OPENING. REPLACEMENT OF THE TUBE WAS DONE.

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

  MAUDE report 21665170 ↗
• MalfunctionFeb 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRE-USAGE INSPECTION, THE 7.5MM ENDOTRACHEAL TUBE'S CUFF WAS DIFFICULT TO INFLATE AND ALSO DIFFICULT TO DEFLATE AIR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410212 ↗
• MalfunctionJan 3, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE'S PILOT BALLOON FELL OFF AFTER INTUBATION. AN EXTUBATION WAS PERFORMED, FOLLOWED BY RE-INTUBATION.

  Patient problems: Unintended Extubation

  MAUDE report 21074752 ↗
• MalfunctionSep 15, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING EXTUBATION IN THE OPERATING ROOM FOR A TRANSITION TO TRACHEOSTOMY, IT WAS DISCOVERED THAT WATER HAD ACCUMULATED IN THE PILOT BALLOON. DURING THE SHIFT CHANGE AMONG NURSES, THE CUFF PRESSURE WAS MEASURED DURING SUCTIONING, AND THE STAFF WHO HANDLED THE PROCEDURE STATED THAT THERE WAS NO WATER AT THAT TIME. ALTHOUGH THE CUFF WAS RECEIVED IN AN INFLATED STATE, UPON INSPECTION, THERE WAS NO WATER ACCUMULATION IN THE CUFF OR INFLATION LINE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20220958 ↗
• MalfunctionSep 13, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TWO ENDOTRACHEAL TUBES DID NOT INFLATE OR DEFLATE PROPERLY WHEN TESTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20210679 ↗
• MalfunctionAug 6, 2024Expiration Date Error; Expiration Date Error

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE "USE BY DATE" OF THE SEVEN ENDOTRACHEAL TUBES WERE SHORT WHICH WAS JUNE 24, 2024. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921242 ↗
• MalfunctionAug 6, 2024Expiration Date Error; Expiration Date Error

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE "USE BY DATE" OF THE SEVEN ENDOTRACHEAL TUBES WERE SHORT WHICH WAS JUNE 24, 2024. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921238 ↗
• MalfunctionAug 6, 2024Expiration Date Error; Expiration Date Error

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE "USE BY DATE" OF THE SEVEN ENDOTRACHEAL TUBES WERE SHORT WHICH WAS JUNE 24, 2024. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921159 ↗
• MalfunctionAug 6, 2024Expiration Date Error; Expiration Date Error

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE "USE BY DATE" OF THE SEVEN ENDOTRACHEAL TUBES WERE SHORT WHICH WAS JUNE 24, 2024. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920879 ↗
• MalfunctionAug 6, 2024Expiration Date Error; Expiration Date Error

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE "USE BY DATE" OF THE SEVEN ENDOTRACHEAL TUBES WERE SHORT WHICH WAS JUNE 24, 2024. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920262 ↗
• MalfunctionAug 6, 2024Expiration Date Error; Expiration Date Error

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE "USE BY DATE" OF THE SEVEN ENDOTRACHEAL TUBES WERE SHORT WHICH WAS JUNE 24, 2024. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920182 ↗
• MalfunctionAug 6, 2024Expiration Date Error; Expiration Date Error

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE "USE BY DATE" OF THE SEVEN ENDOTRACHEAL TUBES WERE SHORT WHICH WAS JUNE 24, 2024. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920068 ↗