Shiley 86452Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10884522000482), received between Sep 4, 2018 and Sep 8, 2026 — classified as 6 deaths, 17 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (20 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Disconnection

  It was reported that newer endotracheal tubes, particularly the 7.5 mm and 8.0 mm sizes, had an extremely loose tube-to-hub connection. The endotracheal tubes reportedly arrived from packaging with the hub loosely connected. During intraoperative use on a patient, the tube-to-hub connection may disconnect. Condensation within the tube reportedly prevented clinicians from advancing the hub further to achieve a tighter fit. A visual difference was observed between the prior and newer tube-to-hub connections, and it was alleged that the newer design may contribute to an insecure connection and potential disconnection during patient use. There was no patient outcome.

  Patient problems: Insufficient Information

  MAUDE report 50667480 ↗
• MalfunctionAug 12, 2026Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 50222364 ↗
• MalfunctionApr 11, 2024Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, WHEN ATTEMPTED A CONVENTIONAL DISCONNECTION OF THE ETCO2 ADAPTOR BY TWISTING, THE SPIKE INSERTED INTO THE HEAD OF THE ENDOTRACHEAL TUBE BROKE IN FOUR PIECES BASED ON THE PHOTO PROVIDED. THE TUBE REMAINED INSERTED IN THE PATIENT AS IT WAS TOO UNSTABLE TO REINTUBATE, AND THE CONNECTOR HEAD WAS REPLACED FROM ANOTHER TUBE. THE PATIENT WAS SUBSEQUENTLY SCOPED TO SEE IF ANY FRAGMENTS REMAINED IN THE TRACHEA, AND THERE WERE NONE FOUND. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092600 ↗
• MalfunctionNov 13, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THREE DAYS AFTER INTUBATION, THE LEAK DETECTOR ON THE VENTILATOR SHOWED AN INCREASE OF OVER (B)(4). THERE WAS NOISE INDICATING A DEFLATED BALLOON, WHICH WAS CONFIRMED BY THE PRESSURE MEASUREMENT. REPRESSURIZATION PERFORMED BUT DID NOT WORK. THE PATIENT WAS URGENTLY REINTUBATED ON AN EICHMANN MANDREL. IT WAS FOUND THAT THE ENDOTRACHEAL TUBE'S BALLOON SPLIT IN TWO.

  Patient problems: Unintended Extubation

  MAUDE report 18127982 ↗
• MalfunctionNov 11, 2023Use of Device Problem; Gas/Air Leak; Insufficient Device Problem Information; Use of Device Problem; Gas/Air Leak; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THREE DAYS AFTER INTUBATION, THE LEAK DETECTOR ON THE VENTILATOR SHOWED AN INCREASE OF OVER 30%. THERE WAS NOISE INDICATING A DEFLATED BALLOON, WHICH WAS CONFIRMED BY THE PRESSURE MEASUREMENT. REPRESSURIZATION PERFORMED BUT DID NOT WORK. THE PATIENT WAS URGENTLY REINTUBATED ON AN "EICHMANN MANDREL". IT WAS FOUND THAT THE ENDOTRACHEAL TUBE'S BALLOON SPLIT IN TWO.

  Patient problems: Unintended Extubation

  MAUDE report 18117009 ↗
• MalfunctionJul 28, 2023Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE CUFF HAD A LEAK WHILE IN USE. IT WAS ALSO STATED THAT THE PACKAGING WAS HARD TO OPEN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412954 ↗
• MalfunctionJul 28, 2023Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE CUFF HAD A LEAK WHILE IN USE. IT WAS ALSO STATED THAT THE PACKAGING WAS HARD TO OPEN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412945 ↗
• MalfunctionJul 27, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF HAD INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410220 ↗
• MalfunctionFeb 16, 2023Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICES WERE PRE-CHECK WITH 10CC OF AIR PRIOR TO INTUBATION. SEVERAL HOURS AFTER INITIAL INTUBATION, THE CUFF OF THE DEVICE BECAME COMPROMISED. THE PATIENT REQUIRED REPLACEMENT OF THE DEVICE USING BOUGIES.

  Patient problems: Unintended Extubation

  MAUDE report 16386995 ↗
• MalfunctionFeb 16, 2023Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, SEVERAL HOURS AFTER INITIAL INTUBATION, THE CUFFS OF THE DEVICES COMPROMISED. THE PATIENT REQUIRED REPLACEMENT OF THE DEVICE USING BOUGIES.

  Patient problems: Unintended Extubation

  MAUDE report 16386954 ↗
• MalfunctionFeb 15, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICES WERE PRE-CHECK WITH 10CC OF AIR PRIOR TO INTUBATION. SEVERAL HOURS AFTER THE INITIAL INTUBATION, THE CUFF OF THE DEVICE BECAME COMPROMISED. THE PATIENT REQUIRED REPLACEMENT OF THE DEVICE USING BOUGIES.

  Patient problems: Unintended Extubation

  MAUDE report 16383161 ↗
• MalfunctionFeb 15, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICES WERE PRE-CHECK WITH 10CC OF AIR PRIOR TO INTUBATION. SEVERAL HOURS AFTER THE INITIAL INTUBATION, THE CUFF OF THE DEVICE BECAME COMPROMISED. THE PATIENT REQUIRED REPLACEMENT OF THE DEVICE USING BOUGIES.

  Patient problems: Unintended Extubation

  MAUDE report 16383122 ↗
• MalfunctionFeb 15, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICES WERE PRE-CHECK WITH 10CC OF AIR PRIOR TO INTUBATION. SEVERAL HOURS AFTER THE INITIAL INTUBATION, THE CUFF OF THE DEVICE BECAME COMPROMISED. THE PATIENT REQUIRED REPLACEMENT OF THE DEVICE USING BOUGIES.

  Patient problems: Unintended Extubation

  MAUDE report 16379554 ↗
• MalfunctionFeb 15, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICES WERE PRE-CHECK WITH 10CC OF AIR PRIOR TO INTUBATION. SEVERAL HOURS AFTER THE INITIAL INTUBATION, THE CUFF OF THE DEVICE BECAME COMPROMISED. THE PATIENT REQUIRED REPLACEMENT OF THE DEVICE USING BOUGIES.

  Patient problems: Unintended Extubation

  MAUDE report 16379430 ↗
• MalfunctionFeb 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, ENDOTRACHEAL CUFFS "RUPTURED". WHEN THE PATIENT HAD LOW OXYGEN READINGS ON PULSE OXIMETER, REPLACEMENT OF TUBE WAS PERFORMED.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 16322890 ↗
• MalfunctionFeb 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, ENDOTRACHEAL CUFFS "RUPTURED". THE PATIENT WAS REQUIRING 6 LITERS PER MINUTE TO MAINTAIN ADEQUATE OXYGENATION. REPLACEMENT OF TUBE WAS PERFORMED.

  Patient problems: Unintended Extubation

  MAUDE report 16309668 ↗
• MalfunctionJan 26, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF WOULD NOT DEFLATE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245952 ↗
• MalfunctionOct 4, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER. THE PATIENT WAS INTUBATED AND NOTED TO HAVE CUFF LEAK AND LOSS OF TIDAL VOLUMES. RESPIRATORY MANAGER TESTED ADDITIONAL TUBES AND FOUND LEAKS THAT MAY BE IN THE SAME LOCATION ON EACH CUFF. THE CONCERN WAS DETECTED AS LOW VENTILATION AS A RESULT OF AN UNDER-INFLATED CUFF RELATED TO THE LEAK.

  Patient problems: Insufficient Information

  MAUDE report 15537175 ↗
• MalfunctionOct 3, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER. THE PATIENT WAS INTUBATED AND NOTED TO HAVE CUFF LEAK AND LOSS OF TIDAL VOLUMES. RESPIRATORY MANAGER TESTED ADDITIONAL TUBES AND FOUND LEAKS THAT MAY BE IN THE SAME LOCATION ON EACH CUFF. THE CONCERN WAS DETECTED AS LOW VENTILATION AS A RESULT OF AN UNDER-INFLATED CUFF RELATED TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15528261 ↗
• MalfunctionOct 3, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER. THE PATIENT WAS INTUBATED AND NOTED TO HAVE CUFF LEAK AND LOSS OF TIDAL VOLUMES. RESPIRATORY MANAGER TESTED ADDITIONAL TUBES AND FOUND LEAKS THAT MAY BE IN THE SAME LOCATION ON EACH CUFF. THE CONCERN WAS DETECTED AS LOW VENTILATION AS A RESULT OF AN UNDER-INFLATED CUFF RELATED TO THE LEAK.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 15528246 ↗
• MalfunctionMay 16, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING SURGERY, THE CUFF OF THE DEVICE FAILED. REINTUBATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 14408349 ↗
• MalfunctionSep 7, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12436307 ↗
• DeathAug 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, WITHIN 10 MINUTES THE UNIT COULD NOT HOLD PRESSURE DUE TO A LEAK AND BALLOON DAMAGE WAS NOTED. AS SETTING UP FOR DECANNULATION/REINTUBATION, THE PATIENT CODED AND DID NOT SURVIVE.

  Patient problems: Insufficient Information

  MAUDE report 12372778 ↗
• MalfunctionAug 18, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, WITHIN 10 MIN OF INTUBATION, THE UNIT COULD NOT HOLD PRESSURE DUE TO LEAKS, AND BALLOON DAMAGE WAS NOTED. SEVERAL MLS WAS ADDED TO THE BALLOON BUT STILL DID NOT HOLD PRESSURE. THE PATIENT WAS REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 12335201 ↗
• MalfunctionMar 16, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD AN INFLATION/DEFLATION ISSUE AND A SLOW CUFF LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496411 ↗