Shiley 18875 (UDI 30884521750351)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 30884521750351), received between Apr 23, 2024 and Jul 3, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE INTUBATION WAS PERFORMED, BUT A SOUND LEAKAGE OCCURRED. AIR WAS INJECTED WITH THE CUFF PRESSURE GAUGE, BUT THE CUFF PRESSURE DID NOT RISE, SO IT WAS REPORTED TO THE DOCTOR. THE POSITION OF THE ENDOTRACHEAL TUBE WAS ADJUSTED, BUT THERE WAS NO IMPROVEMENT IN CUFF PRESSURE. THE ENDOTRACHEAL TUBE WAS REPLACED. IT WAS FOUND THAT THE CUFF WAS TORN WHEN THE REMOVED ENDOTRACHEAL TUBE WAS CHECKED.

  Patient problems: Unintended Extubation

  MAUDE report 22395272 ↗
• InjuryApr 1, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE VENTILATOR INDICATED A DECREASE IN MINUTE VENTILATION (HYPOVENTILATION). THE VENTILATOR CATHETER INTERFACE WAS CHECKED AND FOUND NO AIR LEAKAGE. THE AMOUNT OF GAS IN THE ENDOTRACHEAL TUBE'S BALLOON OF THE BREATHING CATHETER INCREASED AFTER PUMPED OUT. AFTER CONFIRMING THAT THE BALLOON OF THE CATHETER WAS LEAKING AIR, THE ENDOTRACHEAL TUBE WAS REPLACED AND VENTILATION WAS RESUMED, AND THE BREATHING PARAMETERS WERE STABLE.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 21738170 ↗
• InjuryMar 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE VENTILATOR HAD A LEAK ALARM. THE MEDICAL STAFF IMMEDIATELY CHECKED AND FOUND THAT BUBBLES OVERFLOWED FROM THE PATIENT'S MOUTH, THE BLOOD OXYGEN SATURATION DECREASED, AND HYPOXIA OCCURRED. THE MEDICAL STAFF IMMEDIATELY REPLACED THE ENDOTRACHEAL TUBE FOR RE-INTUBATION, THE VENTILATOR ALARM WAS CANCELLED, THE BLOOD OXYGEN SATURATION NO LONGER DECREASED, AND THE HYPOXIA STATE WAS IMPROVED.

  Patient problems: Hypoxia; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 21642192 ↗
• MalfunctionMar 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHEN THE ENDOTRACHEAL TUBE WAS ABOUT TO BE CHANGED TO THE PATIENT, THE NEW ENDOTRACHEAL TUBE THAT WOULD BE PLACED IN WAS TESTED AND FOUND THAT THE CUFF LEAKED AIR. IT WAS REPORTED THAT A TOTAL OF TWO TUBES WERE TESTED PRIOR TO USE HAVING THE SAME ISSUE. THE TUBE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600417 ↗
• MalfunctionMar 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHEN THE ENDOTRACHEAL TUBE WAS ABOUT TO BE CHANGED TO THE PATIENT, THE NEW ENDOTRACHEAL TUBE THAT WOULD BE PLACED IN WAS TESTED AND FOUND THAT THE CUFF LEAKED AIR. IT WAS REPORTED THAT A TOTAL OF TWO TUBES WERE TESTED PRIOR TO USE HAVING THE SAME ISSUE. THE TUBE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600402 ↗
• MalfunctionNov 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AIR LEAKAGE WAS FOUND DURING TRACHEAL INTUBATION. AFTER REPLACING TWO TUBES IN A ROW, THERE WAS STILL AIR LEAKAGE UNTIL THE THIRD TUBE DID NOT LEAK.

  Patient problems: Unintended Extubation

  MAUDE report 20722548 ↗
• MalfunctionNov 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AIR LEAKAGE WAS FOUND DURING TRACHEAL INTUBATION. AFTER REPLACING TWO TUBES IN A ROW, THERE WAS STILL AIR LEAKAGE UNTIL THE THIRD TUBE DID NOT LEAK.

  Patient problems: Unintended Extubation

  MAUDE report 20722529 ↗
• InjurySep 24, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE ENDOTRACHEAL TUBE LEAKED AIR, AND THERE WAS SOUND COMING OUT. THE CUFF PRESSURE WAS TESTED, AND THE CUFF WAS UNABLE TO BE INFLATED. THE TUBE WAS REPLACED IMMEDIATELY. IT WAS ALSO MENTIONED THAT THE PATIENT HAD SERIOUS HARM.

  Patient problems: Hypoventilation; Low Oxygen Saturation; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 20289561 ↗
• MalfunctionMay 7, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PATIENT NEEDED AN ENDOTRACHEAL TUBE TO ASSIST BREATHING, BUT AFTER THE NURSE TOOK OUT THE TUBE AND TRIED IT WITH A SYRINGE, THE CUFF WAS FOUND TO BE LEAKING. THE TUBE WAS REPLACED, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264045 ↗
• InjuryApr 23, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE VENTILATOR SHOWED AIR LEAKAGE AND DECREASED TIDAL VOLUME 30 MINUTES AFTER INTUBATION. A "HISSING" SOUND COULD BE HEARD NEAR THE PATIENT'S ENDOTRACHEAL TUBE AND THE CUFF PRESSURE GAUGE COULD NOT REACH THE TARGET PRESSURE OF 25MMHG WHEN THE CUFF WAS INFLATED. THE AIR LEAKAGE DISAPPEARED AFTER CUFF WAS RE-INFLATED, BUT AIR LEAKED AGAIN AFTER 10 MINUTES AND COULD NOT BE IMPROVED AFTER REPEATED ATTEMPTS. THE TUBE WAS REPLACED AND NO HARM WAS CAUSED TO THE PATIENT. IT WAS STATED THAT WHEN ORIGINAL TUBE WAS PLACED IN WATER AND INFLATED, AIR LEAKAGE COULD BE SEEN.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 19167039 ↗