Shiley 18775SRecalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 10884521620193), received between Aug 15, 2017 and Jul 15, 2026 — classified as 9 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (62 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 125 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Use of Device Problem

  Patient problems: Unintended Extubation

  MAUDE report 25825492 ↗
• MalfunctionJun 4, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT INFLATE PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392141 ↗
• MalfunctionApr 21, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF WAS FOUND DAMAGED AFTER LUBRICANT WAS APPLIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944264 ↗
• MalfunctionApr 17, 2026Material Deformation

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S BEVEL PROCESSING PART OF THE TUBE TIP WAS FOUND CRUSHED AND DEFORMED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911701 ↗
• MalfunctionJan 21, 2026Defective Component

  IT WAS REPORTED THAT PRIOR TO PATIENT INTUBATION, IT WAS NOTICED THAT THE ENDOTRACHEAL TUBE'S TIP HAD DEFORMATION, IT WAS THEN REPLACED WITH ANOTHER TUBE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134517 ↗
• MalfunctionDec 8, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS RESISTANCE DURING CUFF INFLATION AND DEFLATION AFTER ENDOTRACHEAL INTUBATION. IT WAS ALSO STATED THAT VENTILATION WAS PROPERLY PERFORMED EVEN THE INTUBATION TUBE FELT A SENSE OF DISCOMFORT IN THE CUFF. ADDITIONALLY, THERE WAS NO DEFECT SUCH AS HOLES IN THE CUFF, AND AFTER COLLECTION, TRIED TO PERFORMED A CUFF INFLATION AND DEFLATION BUT DID NOT FEEL ANY PARTICULAR SENSE OF DISCOMFORT. THE TUBE WAS REPLACED WITH NO FURTHER IMPACT ON THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 23741028 ↗
• MalfunctionDec 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S CUFF PRESSURE WAS UNSTABLE, AND THERE WERE FREQUENT OCCURRENCES OF LEAKAGE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 23704602 ↗
• MalfunctionDec 2, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AT 11:00 AM, THE PATIENT ON WARFARIN, WHO EXPERIENCED HEAVY BLEEDING FROM BROKEN TEETH, WAS PREPARED FOR TRANSFER TO ANOTHER HOSPITAL. DURING REPOSITIONING, MULTIPLE ATTEMPTS WERE MADE TO REINSERT THE TUBE DUE TO VISIBILITY ISSUES AND CUFF LEAKS. THE FIRST TWO 8.0 ENDOTRACHEAL TUBES PASSED LEAK TESTS, BUT AFTER REPOSITIONING THE PATIENT LATERALLY, IT WAS FOUND THAT THE CUFF HAD A LEAK AND WAS DEFLATED. A 7.5 TUBE WAS USED AND PASSED LEAK TEST; AFTER REPOSITIONING THE PATIENT LATERALLY, THE DOCTOR CHECK THE LUNG AND A LEAK SOUND WAS HEARD AGAIN. IT WAS FOUND THAT THE CUFF OF THE 7.5 TUBE WAS BROKEN. A FOURTH TUBE (SIZE 7.5) WAS TESTED, SHOWED NO LEAKAGE, AND REMAINED FUNCTIONAL, ALLOWING THE PATIENT TO BE SUCCESSFULLY REFERRED.

  Patient problems: Unintended Extubation

  MAUDE report 23700785 ↗
• MalfunctionDec 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT INFLATE DURING THE PRE-USE CHECK. THERE WAS NO CHANGE EVEN THOUGH THE PRESSURE WAS APPLIED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682460 ↗
• MalfunctionNov 21, 2025Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624536 ↗
• MalfunctionAug 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF DID PROPERLY INFLATE/DEFLATE DURING THE PRE-USAGE INSPECTION WHEREIN THE AIR IN THE CUFF WAS DIFFICULT TO ENTER AND EXIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912851 ↗
• MalfunctionJul 9, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF HAD A LEAK AND DID NOT INFLATE WHEN AIR WAS INJECTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460466 ↗
• MalfunctionJun 27, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE ENDOTRACHEAL TUBE'S CUFF CHECK, IT WAS NOTICED THAT AIR WAS LEAKING, IT WAS CHANGED WITH ANOTHER TUBE AND INTUBATION WAS PERFORMED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345230 ↗
• MalfunctionJun 26, 2025Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338258 ↗
• MalfunctionMay 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE ENDOTRACHEAL TUBE HAD STIFFED RESISTANCE INFLATING THE CUFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037129 ↗
• MalfunctionMay 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-TESTING, THREE ENDOTRACHEAL TUBE'S CUFF WERE NOT INFLATING AND AIR WAS NOT HOLDING FROM THE PILOT VALVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943948 ↗
• MalfunctionFeb 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE ENDOTRACHEAL TUBE'S HAD AN INFLATION AND DEFLATION ISSUE, IT WAS OBVIOUSLY DIFFICULT FOR AIR TO ENTER AND COME OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397232 ↗
• MalfunctionFeb 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHEN AIR WAS INSERTED INTO A 7.5MM ENDOTRACHEAL TUBE, THERE WAS MORE RESISTANCE THAN USUAL, AND THERE WAS RESISTANCE IN DEAERATION AS WELL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396215 ↗
• MalfunctionJan 22, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT WAS INTUBATED AFTER PERFORMING A LEAK TEST ON THIS PRODUCT. THE PILOT LINE WAS DETACHED IMMEDIATELY AFTER INTUBATION. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21209298 ↗
• MalfunctionDec 26, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE'S CUFF PRESSURE DID NOT INCREASE. THERE WAS NO PATIENT HARM.

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

  MAUDE report 21023799 ↗
• MalfunctionDec 4, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A 7.5MM INSTRUMENT WITH STYLET DEVICE EXPERIENCED A CUFF INFLATION/DEFLATION ISSUE. SPECIFICALLY, THE CUFF DID NOT INFLATE AS EXPECTED. THE INSPECTION WAS PERFORMED PRIOR TO PATIENT USE, AND NO TUBING LUBRICANT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844685 ↗
• MalfunctionDec 3, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A CUFF INFLATION/DEFLATION ISSUE WITH THE 7.5MM TAPERGUARD A CLINIC SETTING. DURING A PRE-USAGE INSPECTION, IT WAS NOTED THAT THE CUFF DID NOT INFLATE NORMALLY. THE SPECIFIC PRESSURE AND CC USED TO INFLATE THE CUFFS WERE UNKNOWN, AND THE METHOD FOR DETERMINING THE PRESSURE WAS ALSO UNKNOWN. THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835718 ↗
• MalfunctionNov 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ENDOTRACHEAL TUBE'S CUFF WAS POORLY INFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692313 ↗
• MalfunctionOct 28, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-USAGE TESTING, THE ENDOTRACHEAL TUBE HAD DIFFICULTY INJECTING AIR TO THE CUFF USING A SYRINGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544590 ↗
• MalfunctionSep 9, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE'S CUFF DID NOT INFLATE. THE TUBE WAS REPLACED.

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

  MAUDE report 20167972 ↗