Shiley 18765SRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884521620179), received between Apr 20, 2018 and Jul 10, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (22 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787363 ↗
• MalfunctionMar 6, 2026Use of Device Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INJECT AIR INTO THE ENDOTRACHEAL TUBE'S CUFF PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532939 ↗
• MalfunctionJul 2, 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 22388105 ↗
• MalfunctionJul 1, 2025Contamination /Decontamination Problem; Material Split, Cut or Torn; Contamination /Decontamination Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS SOMETHING LIKE A WHITE LINE (STRIPES) ON THE ENDOTRACHEAL TUBE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE PVT VALVE OF THE PILOT BALLOON IS DAMAGED, PRESENTS PRESSURE MARKS AND IT¿S DISTORTED THE SYRINGE CANNOT BE CONNECTED TO THE DEVICE THUS CANNOT BE INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375902 ↗
• 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 21944126 ↗
• 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 21944038 ↗
• MalfunctionDec 3, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, A LEAK OCCURRED AFTER CHANGING THE PATIENT'S BODY POSITION. THE PRESSURE IN THE CUFF WAS ADJUSTED, BUT THE PRESSURE DID NOT STABILIZE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20832547 ↗
• MalfunctionNov 27, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, A LEAK OCCURRED ON THE CUFF OF THE ENDOTRACHEAL TUBE AFTER CHANGING POSITION. THE CUFF PRESSURE WAS ADJUSTED BUT WAS NOT STABLE, SO THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20797433 ↗
• MalfunctionNov 22, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE ENDOTRACHEAL TUBE WAS DIFFICULT TO INFLATE AND REMOVED AIR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761272 ↗
• MalfunctionNov 11, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AIR REMOVAL ON THE ENDOTRACHEAL TUBE'S CUFF COULD NOT BE PERFORMED SMOOTHLY DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651265 ↗
• MalfunctionSep 26, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-USAGE INSPECTION, WHEN INSERTING THE AIR USING A SYRINGE, A FORCE TO PUSH THE SYRINGE WAS NEEDED THAN USUAL TO THE ENDOTRACHEAL TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20316732 ↗
• MalfunctionSep 23, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD STIFFNESS ABNORMALITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287945 ↗
• MalfunctionSep 19, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF WAS STIFF AND INFLATED POORLY DURING CUFF PRE-CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256227 ↗
• MalfunctionSep 11, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE HAD DIFFICULTY ON ENTERING AIR WHEN TESTED. IT WAS STATED THAT THE AIR WAS INSERTED HALFWAY AND STOPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192995 ↗
• MalfunctionSep 4, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS RESISTANCE INJECTING AIR FROM THE SYRINGE DURING THE EXTENSION TEST OF THE CUFF OF THE ENDOTRACHEAL TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138445 ↗
• MalfunctionAug 22, 2024Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ENDOTRACHEAL TUBE'S 15MM CONNECTOR REGION WAS "RUPTURED". THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036998 ↗
• MalfunctionAug 21, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT EXPAND OR DEFLATE NORMALLY WHEN THE AIR WAS INTRODUCED AND EXTRACTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011184 ↗
• MalfunctionJul 23, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-USAGE INSPECTION, AIR COULD NOT BE REMOVED OR INSERTED FROM THE ENDOTRACHEAL TUBE'S CUFF AFTER AIR INJECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813115 ↗
• MalfunctionJul 18, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-TEST, AIR WAS NOT ENTERING IN THE ENDOTRACHEAL TUBE'S INFLATION LINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772954 ↗
• MalfunctionJun 19, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, IT WAS OBSERVED THAT THERE WAS HIGHER RESISTANCE THAN THE USUAL WHEN OPERATING THE ENDOTRACHEAL TUBE'S PILOT BALLOON WITH A SYRINGE BEFORE USE. IT WAS STATED THAT SIMILAR DEFECTS WERE FOUND IN MULTIPLE UNITS FROM THE SAME LOT NUMBER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570534 ↗
• MalfunctionJun 19, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, IT WAS OBSERVED THAT THERE WAS HIGHER RESISTANCE THAN THE USUAL WHEN OPERATING THE ENDOTRACHEAL TUBE'S PILOT BALLOON WITH A SYRINGE BEFORE USE. IT WAS STATED THAT SIMILAR DEFECTS WERE FOUND IN MULTIPLE UNITS FROM THE SAME LOT NUMBER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570530 ↗
• MalfunctionJun 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-TEST, THE ENDOTRACHEAL TUBE'S CUFF DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519048 ↗
• MalfunctionApr 25, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF DID NOT INFLATE BASED ON THE PHOTO PROVIDED, DURING THE PRE-USAGE INSPECTION. THE AIR COULD BE INJECTED BY APPLYING HIGHER PRESSURE THAN USUAL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19184822 ↗
• MalfunctionOct 6, 2023Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE WAS TORN AND DID NOT INFLATE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890906 ↗
• MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE CUFF PRESSURE WAS INSPECTED BY THE USED OF PRESSURE GAUGE BEFORE INTUBATION AND IT WAS CONFIRMED THAT IT WAS NORMAL. AFTERWARDS, THE PATIENT WAS INTUBATED AND UPON ATTEMPTING TO INFLATE THE CUFF, THE CUFF DID NOT INFLATE NORMALLY. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 16217886 ↗