Shiley 18770SRecalls & reported problems

Summary

The FDA's MAUDE database contains 273 adverse event reports that list this exact device (DI 10884521620186), received between Jun 29, 2017 and Sep 16, 2026 — classified as 10 injuries, 263 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (178 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 273 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Use of Device Problem; Material Split, Cut or Torn

  It was reported that the endotracheal tube's cuff did not inflate during the pre-use inspection, and the tip of the tube was cut. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787124 ↗
• MalfunctionAug 25, 2026Use of Device Problem

  It was reported that during the pre-usage inspection, the endotracheal tube's cuff did not inflate. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50432432 ↗
• MalfunctionJul 15, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25831974 ↗
• MalfunctionJul 7, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738694 ↗
• MalfunctionJul 1, 2026Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25684762 ↗
• MalfunctionJun 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING USE OF THE ENDOTRACHEAL TUBE, THERE WAS INABILITY TO REMOVE THE AIR FOR EXTUBATION. THE TUBE WAS REMOVED EVENTUALLY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451088 ↗
• MalfunctionJun 5, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HAD A RESISTANCE WHEN INSERTING/INFLATING WITH AIR, AND THERE WAS ALSO RESISTANCE DURING DEFLATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410940 ↗
• MalfunctionJun 3, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HIGH INFLATION PRESSURE WAS OBSERVED DURING THE CUFF CHECK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25380918 ↗
• MalfunctionMay 28, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP OF THE ENDOTRACHEAL TUBE WAS TORN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25320745 ↗
• MalfunctionApr 20, 2026Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF HAD INFLATION/DEFLATION ISSUE PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933135 ↗
• MalfunctionApr 16, 2026Use of Device Problem

  IT WAS REPORTED THAT WHEN VERIFIED WITH AN AUTOMATIC CUFF MANOMETER, THE ENDOTRACHEAL TUBE'S CUFF INFLATION WAS POOR AS IT DID NOT INFLATE PROPERLY FOR ABOUT 5 SECONDS DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901326 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, AIR INFLATION AND DEFLATION OF THE CUFFS OF THE THREE ENDOTRACHEAL TUBES WERE STIFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678637 ↗
• MalfunctionMar 23, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HAD DEFLATION ISSUE DESPITE NO ISSUES FROM INFLATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665213 ↗
• MalfunctionMar 16, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TWO ENDOTRACHEAL TUBE'S CUFF HAD RESISTANCE DURING AIR INFLATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607994 ↗
• MalfunctionMar 16, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TWO ENDOTRACHEAL TUBE'S CUFF HAD RESISTANCE DURING AIR INFLATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607942 ↗
• MalfunctionFeb 13, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD NO RING MARK PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337135 ↗
• MalfunctionFeb 13, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE CUFF OF THE ENDOTRACHEAL TUBE WAS HARD AND DIFFICULT TO INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337070 ↗
• MalfunctionFeb 9, 2026Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF FAILED TO INFLATE DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298974 ↗
• MalfunctionFeb 5, 2026Use of Device Problem

  IT WAS REPORTED THAT THE AIR WAS DIFFICULT TO PUT IN AND TAKE OUT DURING THE ENDOTRACHEAL TUBE'S CUFF PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273760 ↗
• MalfunctionFeb 5, 2026Use of Device Problem

  IT WAS REPORTED THAT THE AIR WAS DIFFICULT TO PUT IN AND TAKE OUT DURING THE ENDOTRACHEAL TUBE'S CUFF PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273455 ↗
• MalfunctionFeb 5, 2026Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269656 ↗
• MalfunctionJan 28, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE HAD QUITE STRONG RESISTANCE WHEN INJECTING AIR INTO THE CUFF AND WHEN DEFLATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199777 ↗
• MalfunctionJan 23, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PRE-USAGE CHECK, THERE WAS RESISTANCE WHEN AIR WAS INJECTED INTO THE ENDOTRACHEAL TUBE'S CUFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24165373 ↗
• MalfunctionJan 21, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE ENDOTRACHEAL TUBE'S CUFF DID NOT DEFLATE SMOOTHLY OBSERVED FROM THE PILOT LINE AND VALVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131359 ↗
• MalfunctionJan 2, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS NOT PROPERLY INFLATED OR DEFLATED DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943061 ↗