Shiley 86444Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20884522005705), received between Mar 5, 2021 and Jul 28, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN AIRWAY FIRE OCCURRED IN THE OROPHARYNX AT THE BEGINNING OF A TONSILLECTOMY PROCEDURE. A FLASH OF FLAME OBSERVED FOR A SECOND. THE ORAL CAVITY AND PHARYNX WERE IMMEDIATELY IRRIGATED WITH STERILE SALINE, THE ENDOTRACHEAL TUBE WAS REMOVED, AND THE PATIENT WAS REINTUBATED AND TRANSFERRED FOR OBSERVATION. IT WAS REPORTED THAT THE PATIENT HAD A SERIOUS INJURY. THE PATIENT WAS HOSPITALIZED AS A RESULT OF THE EVENT. BRONCHOSCOPY WAS PERFORMED AT THE BEDSIDE AND SHOWED NO SIGNS OF EDEMA, DISCOLORATION, OR OTHER SIGNS OF THERMAL INJURY. NO DEATHS, INFECTIONS, OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 22630622 ↗
• InjuryNov 18, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, MULTIPLE NON-INVASIVE INTERVENTIONS WERE INITIALLY ATTEMPTED WITHOUT SUCCESS. IT WAS THEN DECIDED TO USE VIDEO LARYNGOSCOPY TO VISUALIZE AND REPLACE THE ENDOTRACHEAL TUBE. DURING THIS PROCESS, A SIGNIFICANT KINK WAS OBSERVED IN THE TUBE. WHILE EXCHANGING THE TUBE, THE PATIENT EXPERIENCED SEVERE DESATURATIONS AND A DROP-IN HEART RATE, REQUIRING THE ADMINISTRATION OF ATROPINE TO PREVENT PROGRESSION TO BRADYCARDIC ARREST. THE PATIENT ALSO REQUIRED EXTENSIVE SUCTIONING AND SUFFERED SOME AIRWAY TRAUMA DURING THE EXCHANGE, RESULTING IN BLOODY SECRETIONS AND A SUBSEQUENT DECREASE IN HEMOGLOBIN LEVELS.

  Patient problems: Bradycardia; Hemorrhage/Blood Loss/Bleeding; Low Oxygen Saturation; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 20705581 ↗
• MalfunctionOct 21, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE WAS KINKED AND HAD TO BE REPLACED USING FIBEROPTIC SCOPE. THE KINK WAS CONFIRMED WHEN THE TUBE WAS OUT BY PILOT BALLOON AREA.

  Patient problems: Unintended Extubation

  MAUDE report 20494689 ↗
• InjuryOct 21, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS DIFFICULTY PASSING A SUCTION CATHETER THROUGH THE ENDOTRACHEAL TUBE OF A PEDIATRIC INTENSIVE CARE UNIT (ICU) PATIENT. INITIALLY ATTEMPTED MULTIPLE NON-INVASIVE INTERVENTIONS HAD NO IMPROVEMENT. THE DECISION WAS MADE TO PERFORM VIDEOLARYNGOSCOPY TO VIEW THE TUBE AND CHANGED. ON VISUALIZATION, THE TUBE WAS NOTED TO HAVE SIGNIFICANT KINK, AND DURING EXCHANGE, THE PATIENT EXPERIENCED SIGNIFICANT DESATURATIONS AND DROP IN HEART RATE THAT REQUIRED MEDICATIONS TO PREVENT PROGRESSION OF POSSIBLE BRADY CARDIAC ARREST. THE PATIENT ALSO REQUIRED SIGNIFICANT SUCTIONING AND SOME AIRWAY TRAUMA DURING THE EXCHANGE LEADING TO BLOODY SECRETIONS AND A SUBSEQUENT DROP IN HEMOGLOBIN.

  Patient problems: Bradycardia; Hemorrhage/Blood Loss/Bleeding; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 20494478 ↗
• InjuryJan 17, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE TUBE WAS NOT POSITIONED PROPERLY AND KEPT ON COLLAPSING, PREVENTING VENTILATION OF THE PATIENT. THE A NESTHESIOLOGIST, AND THE SURGEON, REPOSITION TUBING THAT WAS COLLAPSED FROM THE NEAR THIRD AND MIDDLE THIRD. THROUGHOUT THE SURGERY, TO IMPROVE THE PRESSURE WITHIN THE AIRWAY AND THE VENTILATION, THE SURGEON KEPT THE TUBE FROM COLLAPSING AND REPOSITIONED IT AS NEEDED.

  Patient problems: Airway Obstruction; Hypoventilation

  MAUDE report 18528604 ↗
• MalfunctionSep 14, 2023Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE ENDOTRACH'S CUFF WAS NOT INFLATING DUE TO CUFF BREAKAGE DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746618 ↗
• MalfunctionAug 30, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, AFTER OROTRACHEAL INTUBATION, THE ENDOTRACHEAL TUBE CONNECTOR USED TO CONNECT THE CANNULA TO THE VENTILAT ORY SYSTEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650361 ↗
• MalfunctionAug 14, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT VALVE HAD A BREAKAGE DURING THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547355 ↗
• MalfunctionJul 3, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER THE PATIENT WAS INTUBATED, THE ENDOTRACH TUBE'S BALLOON LEAKED AT THE TIME OF INSUFFLATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17246190 ↗
• MalfunctionSep 16, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT WAS ORALLY INTUBATED, AFTER EASY PLACEMENT AND CONFIRMATION OF BILATERAL BREATH SOUNDS AND ETCO2, THE PEDIATRIC ANESTHESIOLOGIST ATTEMPTED A LEAK TEST AT 20 CMH20 BUT WAS UNABLE TO STOP THE LEAK DESPITE OVER-INFLATING THE PILOT BALLOON. THE PLACEMENT WAS CHECKED AGAIN WITH THE CMAC AND CONFIRMED THAT THE CUFF WAS THROUGH THE VOCAL CORDS AND CONTINUED TO HAVE AN UN-SEALABLE LEAKAGE. THE PATIENT HAD A HISTORY OF DIFFICULT AIRWAY. THE PATIENT WAS RE-INTUBATED WITH A SIZE 4.5 CUFFED ETT. IN THE UNLIKELY CASE THAT THE PROBLEM WAS THE TOO SMALL ETT, AND HAD A LEAK THAT WAS SEALABLE AT 20 CMH20. UPON INSPECTION OF THE SIZE 4.0 ETT, NOTED THAT REGARDLESS OF VOLUME PUSHED INTO THE PILOT BALLOON, THE CUFF DID NOT INFLATE AT ALL. UNSURE ABOUT WHERE THE DISCONNECT OR OBSTRUCTION WAS, BUT HAD A LITTLE FUN AND INCREMENTALLY DISSECTED THE ETT TO SEE IF IT COULD ISOLATE THE PROBLEM. THE PILOT BALLOON WAS CUT OFF AND PLACED A 20G ANGIOCATH INTO THE INFLATION TUBE (PILOT LINE) THROUGH WHICH WERE STILL UNABLE TO INFLATE THE CUFF. A WIRE WAS THEN PASSED THROUGH THE INFLATION TUBE, CUFF, TO THE TIP OF THE ETT. TESTED AGAIN WITH ANGIOCATH IN CASE THIS RELIEVED SOME

  Patient problems: Unintended Extubation

  MAUDE report 15442496 ↗
• MalfunctionMar 5, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE HAD A BROKEN CONNECTOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11421083 ↗