Shiley 18755Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884522007563), received between Dec 18, 2018 and Apr 27, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Use of Device Problem

  IT WAS REPORTED THAT AN ENDOTRACHEAL TUBE'S CUFF WAS LEAKING AIR DURING TESTING. THE TUBE WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009636 ↗
• MalfunctionDec 1, 2025Component Missing; Missing Information; Component Missing; Missing Information

  IT WAS REPORTED THAT WHEN OPENING THE 5.5MM ENDOTRACHEAL TUBE, THE DEVICE'S CONNECTOR THAT ADAPTS THE FILTER WAS MISSING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679880 ↗
• MalfunctionNov 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE 5.5MM TRACHEAL TUBE EXPERIENCED A CUFF INFLATION ISSUE AND A CUFF DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631494 ↗
• MalfunctionOct 8, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USAGE, THE ENDOTRACHEAL TUBE'S PILOT LINE HAD A SMALL HOLE THAT CAUSED AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396899 ↗
• MalfunctionApr 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF BROKE DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19098599 ↗
• MalfunctionJan 29, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE HAD INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597745 ↗
• MalfunctionDec 30, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, WHEN THE ENDOTRACHEAL TUBE'S CUFF WAS INFLATED, THERE WAS AN ADHESION ISSUE FROM THE TIP PART, REFER TO A TTACHED PHOTO. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422721 ↗
• MalfunctionOct 11, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF HAD ADHESION ISSUE WHICH BLOCKED THE TUBE DURING USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17915964 ↗
• MalfunctionSep 2, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF WAS "ABNORMAL." THE CUFF WAS INJECTED WITH AIR USING A SYRINGE. THE PATIENT WAS RE-CANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 15351299 ↗
• MalfunctionSep 2, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF WAS "ABNORMAL". THE CUFF WAS INJECTED WITH AIR USING A SYRINGE. THE PATIENT WAS RE-CANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 15351289 ↗
• MalfunctionMar 1, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF DID NOT INFLATE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636737 ↗
• MalfunctionJul 27, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE 'S CUFF HAD AN AIR LEAK WHEN INFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229936 ↗
• MalfunctionJul 27, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE 'S CUFF HAD AN AIR LEAK WHEN INFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229897 ↗
• InjuryDec 18, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE TUBE PRESENTED FOLD IN THE FIRST MARKING THUS CREATING (MEMORY), MAKING IT DIFFICULT FOR THE PATIENT'S BREATHING. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 8176247 ↗