Shiley 18770Recalls & reported problems

Summary

The FDA's MAUDE database contains 434 adverse event reports that list this exact device (DI 10884522007597), received between Nov 6, 2017 and Sep 15, 2026 — classified as 2 deaths, 25 injuries, 407 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (236 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 434 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Use of Device Problem

  It was reported that during pre-usage inspection, the endotracheal tube's cuff had an inflation and deflation issue. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773854 ↗
• MalfunctionAug 12, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225825 ↗
• MalfunctionAug 6, 2026Use of Device Problem; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157816 ↗
• MalfunctionJun 30, 2026Gas/Air Leak; Material Split, Cut or Torn

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

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

  MAUDE report 25664296 ↗
• MalfunctionJun 10, 2026Material Deformation

  IT WAS REPORTED THAT DURING INSERTION OF AN ENDOTRACHEAL TUBE, THE TUBE BENT. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 25462749 ↗
• MalfunctionJun 4, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399215 ↗
• MalfunctionJun 3, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383349 ↗
• MalfunctionMay 14, 2026Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION/DEFLATION ISSUE DURING USED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 25175855 ↗
• MalfunctionMar 31, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, BOTH ENDOTRACHEAL TUBE'S CUFF HAD WATER LEAKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745446 ↗
• MalfunctionMar 31, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, BOTH ENDOTRACHEAL TUBE'S CUFF HAD WATER LEAKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745301 ↗
• MalfunctionMar 12, 2026Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF DID NOT INFLATE DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582419 ↗
• MalfunctionMar 12, 2026Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S BOTH AIR INFLATION AND DEFLATION WERE SLOWER THAN USUAL DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582224 ↗
• MalfunctionMar 9, 2026Material Deformation

  IT WAS REPORTED THAT AFTER TWO DAYS OF USE, THE ENDOTRACHEAL TUBE BECAME SOFT AND KINKED. PATIENT OUTCOME WAS ASKED BUT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24547890 ↗
• MalfunctionMar 2, 2026Use of Device Problem; Obstruction of Flow

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD A CUFF INFLATION AND DEFLATION ISSUE PRIOR TO USE. THE CUFF WAS TESTED PRIOR TO USE WITH A SYRINGE FOR INFLATION AND DEFLATION, BUT THE TEST WAS NOT SUCCESSFUL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491981 ↗
• MalfunctionFeb 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HAD A LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24432176 ↗
• MalfunctionFeb 10, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT INFLATE UNLESS WE PUSHED THE SYRINGE HARDER THAN USUAL PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303776 ↗
• MalfunctionJan 30, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE THE CUFF OF THE ENDOTRACHEAL TUBE HAD CONTRACTION DEAERATION FAILURE WHEREIN THERE WAS MALFUNCTION IN THE CUFF'S INFLATION AND DEFLATION MECHANISM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225354 ↗
• MalfunctionJan 23, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD A LEAK. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24172853 ↗
• MalfunctionJan 22, 2026Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24157695 ↗
• MalfunctionJan 22, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD AN AIR LEAK. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24157575 ↗
• MalfunctionJan 21, 2026Defective Component

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE WAS TWISTED AND BENT AT THE PATIENT'S LARYNX, OBSTRUCTING AIRFLOW AND MAKING SUCTIONING IMPOSSIBLE. A NEW TUBE REPLACEMENT WAS NECESSARY.

  Patient problems: Unintended Extubation

  MAUDE report 24129841 ↗
• MalfunctionJan 9, 2026Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE PILOT VALVE WAS OUT OF ORDER PRIOR TO USE, AT THE HOSPITAL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024471 ↗
• MalfunctionJan 9, 2026Defective Component

  IT WAS REPORTED THAT THE TIP OF THE ENDOTRACHEAL TUBE WAS SOMEWHAT UNEVEN AND ROUGH BASED ON THE PHOTO PROVIDED PRIOR TO USE, AT THE HOSPITAL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024253 ↗
• MalfunctionJan 9, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, THE ENDOTRACHEAL TUBE'S PILOT VALVE HAD ISSUES INFLATING/DEFLATING THE CUFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022390 ↗
• MalfunctionJan 8, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THERE WAS RESISTANCE WHEN INJECTING AIR INTO OR DEFLATING THE CUFF, AND IT BECAME UNUSABLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006988 ↗