Shiley 86450Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 30884522000462), received between Jul 26, 2017 and Sep 28, 2026 — classified as 14 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Connection Problem

  It was reported that immediately after intubation, four back-to-back 15 mm connector pop-off events occurred in the hospital. The connector would not remain in place. A larger adapter from an 8.5 tube was inserted to prevent further connector pop-off. There was no reported patient outcome.

  Patient problems: Insufficient Information

  MAUDE report 50914633 ↗
• MalfunctionMar 11, 2026Use of Device Problem; Connection Problem

  IT WAS REPORTED THAT DURING TESTING OF THE TRACHEOSTOMY TUBE, THE BALLOON CONNECTION WAS NOT SECURE, PRESENTING A RISK THAT THE CONNECTION COULD COME OFF AND CAUSE LOSS OF PRESSURE IN THE CUFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571949 ↗
• InjuryFeb 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S CUFF HAD LEAKAGE, IMAGE WAS PROVIDED AND ATTACHED. AN INJURY OR ADVERSE WAS REPORTED BUT UNDETERMINED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24303429 ↗
• InjuryJan 6, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM DISCONNECTED WHILE BEING ACTIVELY VENTILATED WITH AN AMBU BAG DUE TO SLIGHT REPOSITIONING OF THE AMBU DEVICE WHILE ATTACHED TO THE TUBE. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 23981031 ↗
• InjuryJan 6, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM CONNECTOR DISCONNECTED WHILE THE PATIENT WAS BEING ACTIVELY VENTILATED WITH AN AMBU BAG AFTER THE AMBULANCE HIT A BUMP WHILE TRAVELING DOWN THE ROAD. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 23971249 ↗
• InjuryJan 5, 2026Disconnection

  IT WAS REPORTED THAT WHEN THE FIRST RESPONDERS ARRIVED ON THE SCENE, THE PATIENT WAS ALREADY IN CARDIAC ARREST, RESUSCITATION WAS INITIATED, AND THE PATIENT WAS INTUBATED AS A PART OF THE RESUSCITATIVE EFFORTS. THE ENDOTRACHEAL TUBE'S 15MM DISCONNECTED RIGHT AFTER THE INTUBATION PROCEDURE WAS PERFORMED AS THE STYLET WAS BEING REMOVED FROM THE TUBE. THE FIRST RESPONDER RESOLVED THE ISSUE BY RECONNECTING THE SAME 15MM CONNECTOR BACK ONTO THE TUBE AND RESUMED VENTILATION. THE PATIENT HAD NO RETURN OF SPONTANEOUS CIRCULATION, BUT THE DEATH WAS NOT A RESULT OF A DEVICE MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 23970363 ↗
• MalfunctionJan 5, 2026Disconnection

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBES TOP ADAPTER CAN EASILY BE REMOVE FROM THE TUBE ITSELF WITH MINIMAL EFFORT WHILE STILL IN THE PACKAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969312 ↗
• InjuryJan 5, 2026Disconnection

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S TOP ADAPTER WAS EASILY REMOVED FROM THE TUBE ITSELF AND THE ISSUE OCCURRED WHEN REMOVING THE STYLET. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 23956555 ↗
• MalfunctionJul 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED WHEN THE PHYSICIAN NOTICED A SMALL PIECE OF PLASTIC OR OTHER FOREIGN OBJECT IN THE TUBE BEFORE THE VENTILATOR WAS TURNED ON. THE PATIENT WAS THEN EXTUBATED AND RE- INTUBATED WITH A NEW TUBE. THERE WAS A REPORTED ADVERSE EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 22524033 ↗
• MalfunctionMar 17, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT, THE TRACH HAD A KINK IN THE TUBE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 21617980 ↗
• MalfunctionMar 13, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899109 ↗
• MalfunctionNov 15, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT VALVE BROKE AND GOT DISCONNECTED FROM THE TUBING THAT LED TO THE CUFF ITSELF BASED ON THE PHOTO PROVIDE, DURING THE PROCEDURE. THE TUBE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142892 ↗
• MalfunctionJul 25, 2023Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE WAS DISCOVERED CRACKED AND DAMAGED BEFORE USE. BASED ON THE PHOTO PROVIDED, THE TUBE WAS DEFORMED WITH SHARP EDGE DUE TO MISSING PORTION OF THE EYEPIECE AND THE PILOT BALLOON WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389207 ↗
• MalfunctionJan 6, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE CUFF WOULD NOT REMAIN INFLATED. THE DEVICE WAS SWAPPED TO ANOTHER BRAND AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT.

  Patient problems: Unintended Extubation

  MAUDE report 16112223 ↗
• MalfunctionFeb 23, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE FOUND TO HAVE A BALLOON LEAKAGE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 13589333 ↗
• MalfunctionAug 26, 2021Defective Component; Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN THE MIDDLE OF THE SEPTOPLASTY, THE PEAK AIRWAY PRESSURES INCREASED AND TIDAL VOLUMES DECREASED. UPON INSPECTION AROUND 45 MINUTES INTO THE SURGERY, IT WAS NOTED THAT THERE WAS A KINK DISTAL TO THE TEETH AT APPROXIMATELY 26 CM ON THE DEVICE. ONCE THE KINK WAS LIFTED, THE AIRWAY PRESSURE AND TIDAL VOLUMES RETURNED TO NORMAL. APPROXIMATELY 10 MINUTES BEFORE THE END OF THE CASE, THE TIDAL VOLUMES DROPPED TO LESS THAN 100 ML AND THE AIRWAY PRESSURES WERE FLUCTUATING BETWEEN HIGH AND LOW. UPON LIFTING THE DRAPES TO INSPECT THE DEVICE, A HEAVY ANESTHETIC GAS SMELL WAS NOTED AND A LEAK IN THE DEVICE WAS HEARD AT THE SITE OF THE KINK. THE DEVICE WAS SPLIT AT THE 26 CM POSITION OUTSIDE THE PATIENT¿S MOUTH. THE DEVICE WAS WRAPPED IN TOWELS TO BLOCK THE LEAK AND THE SURGERY WAS FINISHED. THE PATIENT¿S VITAL SIGNS REMAINED STABLE, AND NO REINTUBATION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372923 ↗
• 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 11496045 ↗
• InjuryDec 14, 2020Crack; Crack

  ACCORDING TO THE REPORTER, DURING CODE BLUE AND AFTER INTUBATION, THE HEALTHCARE PROVIDER DISCOVERED THE TUBE WAS MALFUNCTIONING. THE TUBE WAS REMOVED AND FOUND A CRACK.

  Patient problems: Unintended Extubation

  MAUDE report 11003208 ↗
• MalfunctionNov 10, 2020Crack

  DURING CODE BLUE: AFTER INTUBATION, PROVIDER DISCOVERED THE ET TUBE WAS MALFUNCTIONING. TUBE WAS REMOVED AND REPORTEDLY HAD A CRACK IN IT.

  Patient problems: Insufficient Information

  MAUDE report 10816369 ↗
• InjuryJan 2, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO INSERTION, THE DEVICE CUFF POPPED. IT WAS INDICATED THAT RE INTUBATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 9540601 ↗
• InjuryDec 27, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFFED WAS POPPED AFTER INTUBATION. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 9525278 ↗
• InjuryApr 4, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD RESISTANCE ON THE AIR PASSAGE. THE DECANNULATION/REINTUBATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 8484150 ↗
• InjuryApr 4, 2019Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS LOCKED. IT WAS REPORTED THAT THE PATIENT WAS RE INTUBATED.

  Patient problems: Extubate

  MAUDE report 8484058 ↗
• InjuryApr 2, 2019Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE DEVICE FAILED FIRST ATTEMPT DUE TO THE RESISTANCE OF THE CANNULA TO THE PASSAGE OF AIR. IT WAS REPORTED THAT RE-CANNULATION WAS PERFORMED..

  Patient problems: Extubate

  MAUDE report 8476271 ↗
• MalfunctionApr 2, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD LEAKAGE.

  Patient problems: No Information

  MAUDE report 8476268 ↗