Shiley 18870SRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521726697), received between Dec 10, 2021 and May 27, 2026 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Use of Device Problem

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN BOTH INFLATING AND DEFLATING THE AIR INTO THE ENDOTRACHEAL TUBE'S CUFF DURING PRE-USE INSPECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25309426 ↗
• MalfunctionFeb 25, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE AND 15 MM CONNECTOR CONNECTION PART HAD A VERTICAL CRACK ABOUT 1 CM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447359 ↗
• MalfunctionSep 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAK. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 23076100 ↗
• InjuryAug 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE ENDOTRACHEAL TUBE INTUBATION IN THE EMERGENCY ROOM, THE OXYGENATION GRADUALLY IMPROVED, AND VITALS STABILIZED, BUT THE VENTILATOR'S TIDAL VOLUME DECREASED. IT DID NOT IMPROVE EVEN THOUGH THE RESPIRATOR WAS REPLACED, AND WHEN THE READING OF THE CUFF PRESSURE WAS PERFORMED, IT WAS 2 CMH20. CONSIDERING THE POSSIBILITY OF CUFF DAMAGE, THE INTUBATION TUBE WAS REPLACED.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 22921265 ↗
• MalfunctionAug 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WERE FOUR ENDOTRACHEAL TUBES WHEREIN THE CUFFS DID NOT INFLATE AND TWO OF IT WAS CONFIRMED TO HAVE AN AIR LEAK AFTER PLACEMENT ON THE PATIENT. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22897489 ↗
• MalfunctionAug 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WERE FOUR ENDOTRACHEAL TUBES WHEREIN THE CUFFS DID NOT INFLATE AND TWO OF IT WAS CONFIRMED TO HAVE AN AIR LEAK AFTER PLACEMENT ON THE PATIENT. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22897472 ↗
• MalfunctionAug 26, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WERE FOUR ENDOTRACHEAL TUBES WHEREIN THE CUFFS DID NOT INFLATE AND TWO OF IT WAS CONFIRMED TO HAVE AN AIR LEAK AFTER PLACEMENT ON THE PATIENT. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897451 ↗
• MalfunctionAug 26, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WERE FOUR ENDOTRACHEAL TUBES WHEREIN THE CUFFS DID NOT INFLATE AND TWO OF IT WAS CONFIRMED TO HAVE AN AIR LEAK AFTER PLACEMENT ON THE PATIENT. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897446 ↗
• MalfunctionSep 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE HAD AN "ARTICULATION" AND CRACKS AROUND THE 20CM TUBE MEMORY. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20221237 ↗
• MalfunctionMay 7, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT BALLOON WAS NOT PROPERLY FIXED WHEN USE IN COMBINATION WITH AN AUTOMATIC CUFF PRESSURE GAUGE (MADE BY ANOTHER COMPANY) BEFORE USE. IT WAS POSSIBLE TO SUPPLY AIR TO THE CUFF WHEN TRIED TO SUPPLY WITH A SYRINGE, BUT WHEN TRIED AGAIN TO COMBINE IT WITH AN AUTOMATIC CUFF PRESSURE GAUGE, THE CUFF PRESSURE UPPER LIMIT ALARM DID NOT STOP SOUNDING. THERE WAS NO PROBLEMS OBSERVED WHEN COMBINING OTHER TUBES WITH THE AUTOMATIC CUFF PRESSURE GAUGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19263019 ↗
• InjuryJan 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF WAS BROKEN AFTER INSERTION INFLATING WITH 15ML SYRINGE. THERE WAS PRESENCE OF BLOOD AROUND PERFORATED BALLOON. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 18428196 ↗
• MalfunctionSep 8, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE 15MM CONNECTOR OF THE ENDOTRACHEAL TUBE WAS LOOSE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17714498 ↗
• MalfunctionJul 6, 2023Crack; Crack

  ACCORDING TO THE REPORTER, THE TUBE OF THE ENDOTRACHEAL TUBE WAS CRACKED, FOUND AFTER INTUBATION OF THE PATIENT. THE PATIENT HAD REP LACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17266386 ↗
• MalfunctionMar 1, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE DEVICE WAS RUPTURED AND HAD A LEAK. ATTEMPTED MULTIPLE TIMES TO REFILL AIR IN THE BALLOON BUT FAILED. REINTUBATION WAS PERFORMED OVER GUIDEWIRE. AS THE RESPIRATORY THERAPIST (RT) WAS SEPARATING THE OROGASTRIC TUBE FROM ENDOTRACHEAL TUBE, THE RT ACCIDENTALLY PULLED THE ET TUBE OUT AS WELL. PATIENT WAS THEN REINTUBATED VIA DIRECT LARYNGOSCOPY.

  Patient problems: Unintended Extubation

  MAUDE report 13642813 ↗
• MalfunctionDec 10, 2021Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CRACK ON THE PART OF PILOT BALLOON AND THE CUFF WAS SEEN WITHERED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 12976264 ↗