Shiley 86112Recalls & reported problems

Summary

The FDA's MAUDE database contains 181 adverse event reports that list this exact device (DI 10884522000123), received between Nov 20, 2017 and May 27, 2026 — classified as 1 death, 49 injuries, 131 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (59 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 181 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT WAS PRONED WITH 7.5 NON EVAC TUBE AT 23CM AT THE TEETH. THE DEPTH HAD PREVIOUSLY BEEN CONFIRMED VIA CHEST XRAY. UPON UN-PRONING THE PATIENT THERE WAS AIR LEAKING FROM PATIENT'S MOUTH. WHEN THE CUFF WAS CHECKED, IT WAS INFLATED BUT THE PATIENT STILL NOT GETTING ENOUGH VOLUME FROM THE VENTILATOR. WHILE BAGGING THE PATIENT, LARGE AMOUNT OF AIR ESCAPING THE PATIENT'S MOUTH WAS FELT DESPITE HAVING AN INFLATED CUFF. WHEN LOOKING WITH A GLIDE, THE CUFF APPEARED ABOVE THE VOCAL CORDS DESPITE SHOWING TUBE WAS AT THE PREVIOUS CONFIRMED DEPTH, THEN THE PHYSICIAN USED THE BRONCHOSCOPY TO MAKE SURE TUBE WAS STILL IN THE TRACHEA. AS THE TUBE WAS STILL IN THE TRACHEA, THE CUFF WAS DEFLATED AND TUBE WAS PUSHED IN TO 28CM AT THE LIP. DURING BRONCHOSCOPY, IT SHOWED THAT THE TUBE WAS STILL ABOVE THE CARINA, THE CUFF WAS REINFLATED AND THE PATIENT WAS THEN GETTING APPROPRIATE VOLUMES ON VENTILATOR.

  Patient problems: Hypoventilation; Insufficient Information

  MAUDE report 25309168 ↗
• InjuryApr 23, 2026Obstruction of Flow

  IT WAS REPORTED THAT A CUFF CHECK WAS DONE PRIOR TO INSERTING THE STYLET. INITIALLY, THE STYLET WAS A LITTLE DIFFICULT TO INSERT IN THE TUBE BECAUSE THE TUBE WAS OBSTRUCTED OR HAD AN OCCLUSION AND DID MAKE IT IMPOSSIBLE TO VENTILATE THE PATIENT VIA MASK (BVM) . THOUGHT IT WAS BECAUSE THE TUBE WAS SMALL AND THE STYLET WAS VERY CURVED. NOTHING NOTED IN THE TUBE AT THIS TIME. APPLIED LUBRICANT TO THE STYLET AND INSERTED IT IN THE TUBE WITHOUT ISSUE. ABLE TO REMOVE STYLET FROM THE TUBE AFTER INTUBATION WITHOUT DIFFICULTY. ATTEMPTED TO BAG THE PATIENT AND MET A LOT OF RESISTANCE DESPITE VISUALIZATION OF CORDS AND KNOWN BRONCHIAL INTUBATION. THE TUBE WAS REMOVED AND NOTED SMALL DEBRIS AT THE TOP OF THE TUBE, CLOSE TO THE HUB. PATIENT WAS REINTUBATED WITHOUT ISSUE.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 24968047 ↗
• 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 24059531 ↗
• MalfunctionNov 26, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS IDENTIFIED THAT THE (TOT) PNEUMOPONATOR VALVE LOST PRESSURE ON TWO SEPARATE OCCASIONS THROUGHOUT THE PROCEDURE. AS A RESULT, THE MECHANICAL VENTILATION SYSTEM REFLECTED THAT THE CONCERTIN DID NOT RECOVER THE BASELINE VOLUME LEVEL, INDICATING A CHECK FOR LEAKS IN THE CIRCUIT. GIVEN THE PERSISTENCE OF THE FAILURE, A NEW TUBE WAS REQUESTED. BEFORE PROCEEDING WITH THE EXCHANGE, A FUNCTIONALITY TEST WAS PERFORMED ON THE SECOND TUBE, WHERE THE SAME DEFECT WAS OBSERVED: MORE THAN 10 CC OF AIR WAS REQUIRED TO INSUFFLATE THE PNEUMOTAPONATOR AND ONCE INSUFFLATED, THE VALVE REPEATED THE PATTERN OF PRESSURE LOSS. FINALLY, IT WAS DECIDED TO REPLACE THE DEVICE WITH AN 8.0 MM TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 23662801 ↗
• MalfunctionNov 26, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS IDENTIFIED THAT THE (TOT) PNEUMOPONATOR VALVE LOST PRESSURE ON TWO SEPARATE OCCASIONS THROUGHOUT THE PROCEDURE. AS A RESULT, THE MECHANICAL VENTILATION SYSTEM REFLECTED THAT THE CONCERTIN DID NOT RECOVER THE BASELINE VOLUME LEVEL, INDICATING A CHECK FOR LEAKS IN THE CIRCUIT. GIVEN THE PERSISTENCE OF THE FAILURE, A NEW TUBE WAS REQUESTED. BEFORE PROCEEDING WITH THE EXCHANGE, A FUNCTIONALITY TEST WAS PERFORMED ON THE SECOND TUBE, WHERE THE SAME DEFECT WAS OBSERVED: MORE THAN 10 CC OF AIR WAS REQUIRED TO INSUFFLATE THE PNEUMOTAPONATOR AND ONCE INSUFFLATED, THE VALVE REPEATED THE PATTERN OF PRESSURE LOSS. FINALLY, IT WAS DECIDED TO REPLACE THE DEVICE WITH AN 8.0 MM TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662780 ↗
• MalfunctionFeb 24, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S MARKINGS WAS EASILY SMUDGED FROM THE TUBE AS SEEN ON THE IMAGE ATTACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446927 ↗
• MalfunctionJan 9, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE'S BALLOON "RUPTURED", THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21113087 ↗
• MalfunctionApr 26, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PHYSICIAN ATTEMPTED TO PLACE DIFFERENT SIZE 7.5 ENDOTRACHEAL TUBE SEVERAL TIMES DURING THE PROCEDURE BUT THE BALLOON WOULD NOT INFLATE. THE TUBE WAS REPLACED. IT WAS STATED AND CONFIRMED THAT IT WAS DUE TO NOT BEING ABLE TO USE ENOUGH AIR.

  Patient problems: Unintended Extubation

  MAUDE report 19194098 ↗
• MalfunctionApr 26, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PHYSICIAN ATTEMPTED TO PLACE DIFFERENT SIZE 7.5 ENDOTRACHEAL TUBE SEVERAL TIMES DURING THE PROCEDURE BUT THE BALLOON WOULD NOT INFLATE. THE TUBE WAS REPLACED. IT WAS STATED AND CONFIRMED THAT IT WAS DUE TO NOT BEING ABLE TO USE ENOUGH AIR.

  Patient problems: Unintended Extubation

  MAUDE report 19194020 ↗
• MalfunctionJan 31, 2024

  ENDOTRACHEAL TUBE CUFF HAD A PINPOINT HOLE WHICH CAUSED A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623328 ↗
• MalfunctionJan 30, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF FAILED SHORTLY DUE TO LOSS OF AIR. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18608731 ↗
• MalfunctionJan 30, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF FAILED SHORTLY DUE TO LOSS OF AIR. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18608696 ↗
• MalfunctionJan 30, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF FAILED SHORTLY DUE TO LOSS OF AIR. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18608655 ↗
• MalfunctionJan 30, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF FAILED SHORTLY DUE TO LOSS OF AIR. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18608332 ↗
• MalfunctionJan 23, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF LEAK DURING THE PROCEDURE. THE CRNA (CERTIFIED REGISTERED NURSE ANESTHETIST) ATTEMPTED TO ADD MORE AIR TO THE CUFF, AND AFTER INSERTING MORE THAN THE NORMAL AIR, IT WAS DETERMINED THAT THE TUBE HAD A CUFF MALFUNCTION. THE PATIENT WAS EXTUBATED AND REINTUBATED WITH A DIFFERENT TUBE AND NO LEAK WAS NOTED.

  Patient problems: Unintended Extubation

  MAUDE report 18567996 ↗
• MalfunctionDec 12, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE COULD NOT STAY SEALED AFTER INTUBATION. IMMEDIATE TUBE CHANGES WERE MADE AS IT WAS UNABLE TO DETERMINE IF THE ISSUE WAS WITH THE CUFF, PILOT TUBE, OR VALVE, BUT ALL TUBES FAILED WITHIN MINUTES OF BEING PLACED DESPITE APPEARING TO WORK PRIOR TO INTUBATION.

  Patient problems: Unintended Extubation

  MAUDE report 18314230 ↗
• MalfunctionDec 12, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, AFTER INTUBATION AS THE ENDOTRACHEAL TUBE'S CUFFS WOULD NOT STAY SEALED WHICH MADE IMMEDIATE CHANGES, UNABLE TO DETERMINE IF THE ISSUE WAS THE CUFF OR PILOT TUBE/VALVE BUT ALL TUBES HAVE FAILED WITHIN MINUTES OF BEING PLACED DESPITE APPEARING TO WORK PRIOR TO INTUBATION. TUBE WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18313449 ↗
• MalfunctionDec 12, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF FAILED SHORTLY AFTER INTUBATION DUE TO LOSS OF AIR. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18313444 ↗
• MalfunctionDec 12, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, AFTER INTUBATION AS THE ENDOTRACHEAL TUBE'S CUFFS WOULD NOT STAY SEALED WHICH MADE IMMEDIATE CHANGES, UNABLE TO DETERMINE IF THE ISSUE WAS THE CUFF OR PILOT TUBE/VALVE BUT ALL TUBES HAVE FAILED WITHIN MINUTES OF BEING PLACED DESPITE APPEARING TO WORK PRIOR TO INTUBATION. TUBE WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18313439 ↗
• MalfunctionDec 12, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, AFTER INTUBATION AS THE ENDOTRACHEAL TUBE'S CUFFS WOULD NOT STAY SEALED WHICH MADE IMMEDIATE CHANGES, UNABLE TO DETERMINE IF THE ISSUE WAS THE CUFF OR PILOT TUBE/VALVE BUT ALL TUBES HAVE FAILED WITHIN MINUTES OF BEING PLACED DESPITE APPEARING TO WORK PRIOR TO INTUBATION. TUBE WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18313425 ↗
• MalfunctionDec 12, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, AFTER INTUBATION AS THE ENDOTRACHEAL TUBE'S CUFFS WOULD NOT STAY SEALED WHICH MADE IMMEDIATE CHANGES, UNABLE TO DETERMINE IF THE ISSUE WAS THE CUFF OR PILOT TUBE/VALVE BUT ALL TUBES HAVE FAILED WITHIN MINUTES OF BEING PLACED DESPITE APPEARING TO WORK PRIOR TO INTUBATION. TUBE WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18313329 ↗
• MalfunctionDec 12, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE COULD NOT STAY SEALED AFTER INTUBATION. IMMEDIATE TUBE CHANGES WERE MADE AS IT WAS UNABLE TO DETERMINE IF THE ISSUE WAS WITH THE CUFF, PILOT TUBE, OR VALVE, BUT ALL TUBES FAILED WITHIN MINUTES OF BEING PLACED DESPITE APPEARING TO WORK PRIOR TO INTUBATION.

  Patient problems: Unintended Extubation

  MAUDE report 18312891 ↗
• MalfunctionDec 12, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE COULD NOT STAY SEALED AFTER INTUBATION. IMMEDIATE TUBE CHANGES WERE MADE AS IT WAS UNABLE TO DETERMINE IF THE ISSUE WAS WITH THE CUFF, PILOT TUBE, OR VALVE, BUT ALL TUBES FAILED WITHIN MINUTES OF BEING PLACED DESPITE APPEARING TO WORK PRIOR TO INTUBATION.

  Patient problems: Unintended Extubation

  MAUDE report 18312852 ↗
• MalfunctionDec 12, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE COULD NOT STAY SEALED AFTER INTUBATION. IMMEDIATE TUBE CHANGES WERE MADE AS IT WAS UNABLE TO DETERMINE IF THE ISSUE WAS WITH THE CUFF, PILOT TUBE, OR VALVE, BUT ALL TUBES FAILED WITHIN MINUTES OF BEING PLACED DESPITE APPEARING TO WORK PRIOR TO INTUBATION.

  Patient problems: Unintended Extubation

  MAUDE report 18312817 ↗
• MalfunctionOct 26, 2023Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE HAD A DAMAGE IN THE "PNEUMOTAPONATOR" AFTER 8-10 DAYS OF BEING VENTILATED. WHEN THE PRESSURE WAS CHECKED WITH THE PRESSURE GAUGE, PRESSURE SHOWED FROM 30 TO 50 CMH2O. THE PATIENT WAS LEAKING THROUGH THE "TOT" WALLS. THE VOLUMES THAT THE PATIENT WAS SCHEDULED TO ESCAPE THROUGH THE WALLS OF THE TRACHEA WERE LOST, AS THE BALLOON SECURING THE TUBE TO THE TRACHEA LOSES ITS FUNCTIONALITY. WHEN TOT EXCHANGE WAS PERFORMED FOR THIS DYSFUNCTION, IT WAS NOTED THAT, DESPITE DEFLATING THE PNEUMOTAPONATOR, WHEN REMOVING THE PATIENT¿S TUBE, THE BALLOON MAINTAINS SOME BALLOON DISTENTION.

  Patient problems: Unintended Extubation

  MAUDE report 18013403 ↗

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