Shiley 86113Recalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 10884522000130), received between Feb 6, 2018 and Jul 28, 2026 — classified as 16 deaths, 61 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (90 reports).

1 other recall cover devices cleared under the same FDA submission (K871204); they may or may not involve this specific model.

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 186 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063596 ↗
• InjuryFeb 9, 2026Connection Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY, PATIENT WAS INTUBATED WITH ENDOTRACHEAL TUBE (ETT) DURING CPR USING LAERDAL BAG ATTACHED TO THE ETT WITH A FILLER AND ETC02 DETECTOR. THE ETT BEGAN FILLING WITH BLOOD. AS GETTING READY TO SWITCH THE ETC02 DETECTOR OUT AND PLACE AN INLINE SUCTION, THE 15MM CONNECTOR POPPED OFF FROM THE TUBE, SPRAYING BLOOD EVERYWHERE. THE TUBE WAS QUICKLY REPLACED AND TIGHTENED THE ADAPTOR TO THE ETT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Extubation

  MAUDE report 24290607 ↗
• MalfunctionJan 13, 2026Use of Device Problem

  IT WAS REPORTED THAT THERE WERE ERRORS WITH PROPER INFLATION OF THE ENDOTRACHEAL TUBE'S CUFFS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24059580 ↗
• MalfunctionNov 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT WHILE THE PATIENT WAS BOOSTING IN BED, THE TRACH TUBE CAME PART WAY OUT. UPON ASSESSING THE TUBE JUST SLID VERY EASILY THROUGH THE BITE LOCK AND WAS TOO FAR OUT TO PUSH BACK IN, PATIENT WAS BAGGED WHILE PREPARING TO RE-INTUBATE. PATIENT WAS REINTUBATED WITH NO COMPLICATIONS AND PLACEMENT WAS VERIFIED VIA X-RAY.

  Patient problems: Unintended Extubation

  MAUDE report 23512250 ↗
• MalfunctionSep 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT CUFF WAS TORN ALMOST IMMEDIATELY AFTER USE FOR INTUBATION DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020488 ↗
• MalfunctionSep 2, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE EXHIBITED KINKING IN THE ORO-PHARYNX ALONG THE JUNCTION OF PILOT BALLOON AND TUBE SHAFT. THIS KINK HAS BEEN PREVENTING SUCTION CATHETERS TO PASS DOWN THE TUBE. ALSO, IT WAS CAUSING THE TIP OF TUBE TO MIGRATE UP POSSIBLY WITH THE KINK ANCHORING TO HARD PALATE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 22945721 ↗
• InjuryAug 11, 2025Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE EXHIBITED KINKING IN THE ORO-PHARYNX ALONG THE JUNCTION OF THE PILOT BALLOON AND TUBE SHAFT DURING USE IN A HOSPITAL SETTING. THIS KINK OBSTRUCTED THE PASSAGE OF SUCTION CATHETERS THROUGH THE TUBE AND CAUSING MIGRATION OF THE TUBE TIP UPWARDS, WITH THE POSSIBILITY OF THE KINK ANCHORING TO THE HARD PALATE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Hypoventilation; Insufficient Information; Respiratory Insufficiency; Unintended Extubation

  MAUDE report 22772408 ↗
• MalfunctionAug 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CUFF OF THE SIZE 8 ENDOTRACHEAL TUBE EXPERIENCED "RUPTURE" DESCRIBED DURING A PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717637 ↗
• MalfunctionAug 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CUFF OF THE SIZE 8 ENDOTRACHEAL TUBE EXPERIENCED "RUPTURE" DESCRIBED DURING A PROCEDURE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22691227 ↗
• MalfunctionMay 6, 2025Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE KINKED AND OCCLUDED DURING TURNING. THERE WAS NO PATIENT INJURY. THE MEDICAL INTERVENTION WAS TO ROLL THE PATIENT TO A SUPINE POSITION AND MANUALLY STRAIGHTEN THE ENDOTRACHEAL TUBE TO ALLOW VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969764 ↗
• InjuryApr 2, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE USE OF AN ENDOTRACHEAL TUBE (ETT), THE PATIENT EXPERIENCED LOW OXYGEN SATURATIONS AND SNORING RESPIRATIONS. INITIALLY, THE CUFF OF THE ETT WAS INFLATED WITH 10ML OF AIR. AN ADDITIONAL 2ML OF AIR WAS ADDED TO THE CUFF, WHICH TEMPORARILY IMPROVED THE SITUATION. HOWEVER, THE PATIENT AGAIN EXPERIENCED LOW OXYGEN SATURATIONS AND SNORING RESPIRATIONS, PROMPTING THE ADDITION OF ANOTHER 4ML OF AIR TO THE CUFF. DESPITE THESE EFFORTS, LOW OXYGEN SATURATIONS PERSISTED. THE PATIENT WAS REINTUBATED, AND UPON EXAMINATION, IT WAS FOUND THAT THE CUFF HAD A LEAK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Oxygen Saturation; Snoring; Unintended Extubation

  MAUDE report 21752304 ↗
• MalfunctionJan 4, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PILOT BALLOON DETACHED FROM ENDOTRACHEAL TUBE WHILE IN USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075325 ↗
• MalfunctionDec 4, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ENDOTRACHEAL TUBE'S CUFF DEFLATES WHEN INFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849820 ↗
• MalfunctionAug 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ENDOTRACHEAL TUBE'S PILOT BALLOON SEAM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986096 ↗
• InjuryAug 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE TUBE WAS PLACED AND PLACEMENT WAS CONFIRMED BY AN END TIDAL COLORIMETRIC DEVICE. THE PATIENT COULD NOT BE VENTILATED EVEN AFTER REPOSITIONING, AS IF THE TUBE WAS BLOCKED. THE PATIENT WAS REINTUBATED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 19951091 ↗
• MalfunctionAug 7, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF HAD A LEAK DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927675 ↗
• MalfunctionMay 24, 2024Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, IT WAS FOUND THAT THE TIP OF THE ENDOTRACHEAL TUBE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397954 ↗
• MalfunctionNov 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE HAD A LEAK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234062 ↗
• MalfunctionNov 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE HAD A LEAK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231125 ↗
• MalfunctionNov 20, 2023Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF HAD A LEAK, BUT THE CUFF PRESSURE WAS GREATER THAN 100 DURING THE PROCEDURE. THE PATIENT WAS EXTUBATED TO BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) AND ENDED UP BEING REINTUBATED. IT WAS NOTED THAT THE PATIENT BIT A HOLE IN THE TUBE CAUSING THE LEAK.

  Patient problems: Unintended Extubation

  MAUDE report 18175065 ↗
• MalfunctionSep 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, WHEN THE PATIENT WAS INTUBATED AND WAS CONNECTED TO THE ANESTHETIC MACHINE, THE ANESTHETIST WAS UNABLE TO VENTILATE THE PATIENT. THE TUBE'S BALLOON WAS CHECK AND NO LEAKS FOUND. THE CIRCUIT COMPONENTS OF ANESTHETIC MACHINE WAS CHANGE WITH NO CHANGE IN LEAK STATUS. THE PATIENT WAS ATTACH TO AN AMBU BAG FOR VENTILATION AND MAINTAINED ON TIVA (TOTAL INTRAVENOUS ANESTHESIA). THE ANESTHETIC MACHINE WAS REPLACED AND STILL UNABLE TO VENTILATE THE PATIENT. THE TUBE'S BALLOON WAS CHECK AGAIN AND STILL NO LEAKS. THE PATIENT CONTINUED TO BE VENTILATED VIA AMBU BAG, THEN THE PATIENT WAS REINTUBATED WITH A SIZE 7.5 TUBE. WHEN THE PATIENT WAS RECONNECTED TO THE ANESTHETIC MACHINE, THE VENTILATION WAS SUCCESSFUL.

  Patient problems: Unintended Extubation

  MAUDE report 17730536 ↗
• MalfunctionJul 13, 2023Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF REQUIRED A LOT OF AIR (PRESSURE) TO BE FULLY INFLATED, IT WAS NOT POSSIBLE TO CONFIRM THE CUFF PRESSURE WHEN CUFF WAS INFLATED AND THE CUFF WAS DEFORMED UPON INFLATION BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320838 ↗
• MalfunctionJul 7, 2023Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT VALVE REQUIRED A LOT OF AIR (PRESSURE) TO BE FULLY INFLATED, IT WAS NOT POSSIBLE TO CONFIRM THE CUFF PRESSURE WHEN CUFF WAS INFLATED AND THE CUFF WAS DEFORMED UPON INFLATION BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283381 ↗
• MalfunctionJul 7, 2023Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT VALVE REQUIRED A LOT OF AIR (PRESSURE) TO BE FULLY INFLATED, IT WAS NOT POSSIBLE TO CONFIRM THE CUFF PRESSURE WHEN CUFF WAS INFLATED AND THE CUFF WAS DEFORMED UPON INFLATION BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283363 ↗
• InjuryJun 30, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S END WAS OCCLUDED BY PLASTIC BUBBLE THAT RESULTED IN A COMPLETE BLOCK OF AIRFLOW. THE TUBE WAS REPLACED.

  Patient problems: Airway Obstruction; No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 17240667 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K871204. One submission often covers many models, so check the product and lot details in each record.

• Z-1318-2023 · Feb 10, 2023 · Open, Classified
  COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal in