Shiley 18785Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884522007627), received between Aug 13, 2017 and Sep 23, 2026 — classified as 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (8 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 23, 2026Use of Device Problem

  It was reported that the endotracheal tube had a leak in the balloon inflation tube during patient use. The balloon was inflated several times but repeatedly deflated. The product was tested in water to locate the leak. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868803 ↗
• MalfunctionJun 2, 2026Material Deformation

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE COLLAPSED BETWEEN 17 AND 19 CM DURING INTUBATION MANAGEMENT WHEN A 2.2 MM THERAPEUTIC BRONCHOSCOPE WAS GOING TO BE INTRODUCED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 25367704 ↗
• InjuryApr 27, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S PILOT BALLOON LOOSE PRESSURE AFTER INTUBATION. THE ISSUE LED TO RESPIRATORY DISTRESS FOR THE PATIENT AND URGENT REINTUBATION WAS NECESSARY AS THE DEVICE IS NOT AIRTIGHT.

  Patient problems: Respiratory Insufficiency; Unintended Extubation

  MAUDE report 25009643 ↗
• InjuryApr 27, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PATIENT USE OF AN ENDOTRACHEAL TUBE, THERE WAS AN ISSUE INVOLVING THE PILOT BALLOON. THE ISSUE LED TO SERIOUS COMPLICATIONS FOR THE PATIENT WHO NEEDED EMERGENCY REINTUBATION. THE PATIENT WAS REPORTED TO BE IN CRITICAL STATE.

  Patient problems: Unintended Extubation

  MAUDE report 25009628 ↗
• MalfunctionSep 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BEFORE THE SURGERY, THE TRACHEAL TUBE WAS INTUBATED, AND REMAINED INTUBATED FOR 9 DAYS AFTER SURGERY, BUT IT WAS FOUND THAT AN AIR LEAK OCCURRED DUE TO A VENTILATOR ALARM. THE TRACHEAL TUBE WAS EXTUBATED, AND ANOTHER TRACHEAL TUBE WAS INTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 23023150 ↗
• InjuryJun 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, BOTH ENDOTRACHEAL TUBE'S CUFF DEFLATED. PATIENT HAD BREATHING DISTRESS. THE TUBES WERE REPLACED.

  Patient problems: Adult Respiratory Distress Syndrome; Unintended Extubation

  MAUDE report 22298172 ↗
• MalfunctionFeb 6, 2025Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INTUBATION DEPTH MARKING ENDOTRACHEAL TUBES FADED, NECESSITATING RE-INTUBATION OF THE PATIENT EVERY TWO OR THREE DAYS.

  Patient problems: Unintended Extubation

  MAUDE report 21318965 ↗
• MalfunctionFeb 3, 2025Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INTUBATION DEPTH MARKING ENDOTRACHEAL TUBES FADED, NECESSITATING RE-INTUBATION OF THE PATIENT EVERY TWO OR THREE DAYS.

  Patient problems: Unintended Extubation

  MAUDE report 21289917 ↗
• MalfunctionFeb 21, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE OROTRACHEAL CANNULA WAS LOOSE, WHICH CAUSED THE DISCONNECTION OF MECHANICAL VENTILATION PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754968 ↗
• MalfunctionFeb 13, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AIR CAME OUT OF THE ENDOTRACHEAL TUBE'S CUFF IMMEDIATELY WHEN INSERTED DURING PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696545 ↗
• MalfunctionJun 23, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT BALLOON RUPTURED DURING THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17191220 ↗
• MalfunctionMar 9, 2023Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE ANESTHESIA MACHINE'S TIDAL VOLUME WAS CONTINUOUSLY DECREASING DURING THE PROCEDURE. THE TUBE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unintended Extubation

  MAUDE report 16514364 ↗
• MalfunctionSep 7, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF WAS PRE-TESTED AND DID NOT INFLATE, LEAK WAS OBSERVED IN THE PILOT BALLOON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372356 ↗
• MalfunctionMar 29, 2022Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD A LEAK AND AIR WAS COMING OUT AFTER 2 WEEKS OF INTUBATION. PATIENT WAS REINTUBATED. WHEN SALINE WAS INJECTED INTO THE POST-EXTUBATION CUFF AND CHECKED, IT WAS CONFIRMED THAT LEAK OCCURRED, SO IT WAS REPORTED AS A BROKEN CUFF.

  Patient problems: Unintended Extubation

  MAUDE report 13939945 ↗
• MalfunctionNov 2, 2021Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, WHEN A TEST WAS PERFORMED TO INFLATE THE CUFF, IT WAS STUCK AND WOULD NOT INFLATE. THERE WAS A CUT PRESENT WHEN OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739094 ↗
• InjuryJun 15, 2021Defective Component; Human-Device Interface Problem; Defective Component; Human-Device Interface Problem

  ACCORDING TO LITERATURE SOURCE OF CLINICAL REPORTS, THE PATIENT WITH CHRONIC HEART FAILURE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) DUE TO RESPIRATORY FAILURE. IMMEDIATELY BEFORE ADMISSION, THE PATIENT'S AIRWAY WAS STABILIZED USING A CUFFED 8.5MM TRACHEAL TUBE. THE AIR LEAKAGE DID NOT STOP WITH THE REGULAR INTRACUFF PRESSURE (25CM H2O) DUE TO THE TRACHEAL TUBE MISMATCH. THE DIAMETER OF THE PATIENT'S TRACHEA WAS TOO LARGE FOR THE TUBE USED- A DIAMETER OF 28.6MM. A HIGHER INTRACUFF PRESSURE OF 35CM H2O WAS APPLIED TO PREVENT AIR LEAKAGE AND TRACHEAL TUBE MOVEMENT. THREE DAYS AFTER ADMISSION, A CHEST X-RAY SHOWED A MEDIAL STRIPE SIGN AND BASILAR HYPERLUCENCY INDICATING PNEUMOMEDIASTINUM AND PNEUMOTHORAX. PATIENT'S AIRWAY WAS CONVERTED TO PERCUTANEOUS TRACHEOSTOMY.

  Patient problems: Adult Respiratory Distress Syndrome; Pneumothorax; Unintended Extubation

  MAUDE report 12005881 ↗
• MalfunctionDec 30, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE TUBE STAFF WAS STIFF. THE TUBE CAUSED TRAUMA TO PATIENT'S MOUTH WHILE INTUBATED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11094334 ↗
• InjuryDec 21, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER INTUBATION, THERE WAS AIR LEAK FROM THE CUFF, SO IT WAS EXTUBATED AND THE PRODUCT WAS CHECKED. ALTHOUGH THE CUFF WAS IN THE CONDITION THAT HAD NO DAMAGE VISUALLY, NEITHER AIR INJECTION NOR DEFLATION COULD BE PERFORMED. DECANNULATION WAS PERFORMED, AND REINTUBATION WAS PERFORMED WITH ANOTHER TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 11047600 ↗
• InjuryNov 3, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE SHOWED A DROP IN SATURATION AS WELL AS AIR LEAK WHEN EXTUBATION WAS PERFORMED; IT WAS VERIFIED THAT THE CUFF WAS LEAKING. THE PROBLEM WAS INITIALLY BEING DETECTED AFTER INTUBATION SOMETIMES ON THE SAME DAY, OTHERS AFTER 24 HOURS. AS THE PROBLEM BECAME A CONSTANT, THE TEAMS ROUTINELY CHECKED THE PRESSURE OF THE CUFF USING THE CUFFNOMETER, AND THEN THE FAULTS STARTED TO BE DETECTED.

  Patient problems: Extubate; Low Oxygen Saturation

  MAUDE report 10776785 ↗
• InjuryAug 19, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICES HAD CUFF LEAKAGE. THE PATIENT HAD AN IMMEDIATE TUBE EXCHANGED.

  Patient problems: Extubate

  MAUDE report 10425790 ↗
• MalfunctionJul 27, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A SLIGHTLY WIDER TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10325465 ↗
• MalfunctionApr 16, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS BLOWN DURING USE. PATIENT WAS ALERT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968179 ↗
• InjuryMar 18, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING USE OF THE DEVICES, A CUFF INFLATION/DEFLATION ISSUE OCCURRED. IT WAS INDICATED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS THOUGH PATIENT HAD TO BE REINTUBATED.

  Patient problems: No Information

  MAUDE report 8429819 ↗
• MalfunctionNov 27, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, UPON INFLATION, THE DEVICE'S CUFF DID NOT STAY INFLATED. IT WAS REPORTED THAT THE TEST WAS REDONE PRIOR TO REMOVAL OF THE TUBE FROM PACKAGING FOR FURTHER REVIEW. CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8109036 ↗
• MalfunctionNov 19, 2018Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8084279 ↗