Shiley 18760Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 80884522007572), received between May 1, 2018 and Sep 8, 2026 — classified as 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (11 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677292 ↗
• MalfunctionFeb 11, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD AN AIR LEAK PRIOR TO USE, WHILE AT THE HOSPITAL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317370 ↗
• MalfunctionFeb 7, 2025Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USAGE, THE ENDOTRACHEAL TUBE'S SLIP JOINT WAS FOUND BROKEN AFTER OPENING FROM THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332135 ↗
• MalfunctionJan 8, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING USE, THE ENDOTRACHEAL TUBE'S 15 MM CONNECTOR WAS EASY TO DISCONNECT/COME OFF. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21106219 ↗
• MalfunctionMay 6, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, BOTH CUFF'S OF THE ENDOTRACHEAL TUBE WERE NOT INFLATING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19248146 ↗
• MalfunctionSep 19, 2023Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE CONNECTOR TUBE WAS LOOSE AND EASILY DETACHES FROM THE ENDOTRACHEAL TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773661 ↗
• MalfunctionAug 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A NEWLY OPENED ENDOTRACHEAL TUBE'S CUFF WAS FOUND DETACH FROM THE TUBE BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647015 ↗
• MalfunctionJan 31, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF WAS TESTED PRIOR TO USE AND THE CUFF'S AIR INJECTION AND EXTRACTION WAS NOT POSSIBLE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274604 ↗
• MalfunctionOct 26, 2021Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF SIX DEVICES HAD AN AIR LEAK UPON INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698734 ↗
• MalfunctionSep 20, 2021Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE CUFF WAS INJECTED WITH AIR BUT IT DID NOT INFLATE WELL. THE CUFF WAS DAMAGED BY ABOUT 1MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497007 ↗
• MalfunctionJul 27, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S CUFF HAD AN AIR LEAK UPON INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232372 ↗
• MalfunctionJul 27, 2021Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231561 ↗
• MalfunctionJul 27, 2021Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231535 ↗
• MalfunctionJul 27, 2021Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231515 ↗
• MalfunctionJul 27, 2021Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231497 ↗
• MalfunctionJul 27, 2021Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229903 ↗
• MalfunctionMay 10, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOT ALLOWED TO BALLOON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802780 ↗
• MalfunctionMay 5, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A BALLOON DEFECT (ASYMMETRY). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776205 ↗
• InjurySep 26, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TUBE HAD CUFF INFLATION/DEFLATION ISSUE. REINTUBATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 9123081 ↗
• MalfunctionAug 13, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TUBE HAD CUFF INFLATION/DEFLATION ISSUE. REINTUBATION WAS REQUIRED.

  Patient problems: Extubate; No Information

  MAUDE report 8886489 ↗
• InjuryAug 5, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PILOT VALVE OF THE ELEVEN TUBES DEFLATED IN A SHORT PERIOD. IT WAS REPORTED THAT THE TUBE LOST PRESSURE AFTER 2 TO 3 DAYS ON AVERAGE AND WAS TESTED WITH CUFOMETER WITH PRESSURE NOT STABLE. AFTER TAKING OUT OF THE PATIENT, THE TUBE WAS TESTED AND THERE WAS NO LEAKAGE IN THE CUFF. REINTUBATION WAS REQUIRED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION.

  Patient problems: No Information

  MAUDE report 8858776 ↗
• InjuryAug 5, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PILOT VALVE OF THE ELEVEN TUBES DEFLATED IN A SHORT PERIOD. IT WAS REPORTED THAT THE TUBE LOST PRESSURE AFTER 2 TO 3 DAYS ON AVERAGE AND WAS TESTED WITH CUFOMETER WITH PRESSURE NOT STABLE. AFTER TAKING OUT OF THE PATIENT, THE TUBE WAS TESTED AND THERE WAS NO LEAKAGE IN THE CUFF. REINTUBATION WAS REQUIRED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION.

  Patient problems: No Information

  MAUDE report 8858761 ↗
• InjuryFeb 4, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS LEAKING. THERE WAS PATIENT RE-INTUBATION BUT THE PATIENT WAS STABLE.

  Patient problems: Extubate

  MAUDE report 8303195 ↗
• InjuryDec 18, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, ONE MINUTE AFTER THE START OF USING THE PRODUCT, AIR DID NOT ENTER THE CUFF. IT WAS INDICATED THAT RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED/PERFORMED.

  Patient problems: Extubate

  MAUDE report 8176397 ↗
• MalfunctionSep 24, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS AN AIR LEAKING WHEN INFLATING THE DEVICE¿S CUFF. IT WAS REPORTED THAT THE TIP PART OF THE CUFF SEEMED TO BE DISTORTED WHEN INFLATED. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7903100 ↗