Shiley 86234 (UDI 10884521797260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521797260), received between Sep 29, 2021 and Jan 6, 2026 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Defective Component” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026

  WHEN ATTEMPTING TO PREPARE A 3.0 ETT FOR RE INTUBATION. I WAS TRYING TO PULL THE HUB OFF TO LOOSEN IT AND THE HUB BROKE INTO 2 PIECES. 3.0 SHILEY ETT LOT 25C0363JZX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973558 ↗
• MalfunctionDec 8, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN REMOVING THE ENDOTRACHEAL TUBE FROM THE AIRWAY THE 15MM CONNECTOR FELL OFF. THERE WAS NO PATIENT HARM DUE TO PROVIDER BEING UNABLE TO INTUBATE, LMA (LARYNGEAL MASK AIRWAY) WAS USED WITHOUT ISSUE AND INFANT IMPROVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741647 ↗
• MalfunctionNov 20, 2025Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USAGE, THE FRONT OF THE PIPE WALL WAS CRACKED AND DAMAGED ON THE ENDOTRACHEAL TUBE, AS SOON AS THE PACKAGING WAS OPENED, SEE ATTACHED IMAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609329 ↗
• MalfunctionNov 17, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO USAGE, THE VISUAL INSPECTION IMMEDIATELY AFTER OPENING, THE TIP SIDE OF THE ENDOTRACHEAL TUBE SEEMED LIKE IT WAS PRESSED/CRUSHED AND THE TIP SIDE PART WAS CRUSHED AND DEFORMED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569524 ↗
• MalfunctionJul 17, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE CONNECTION WAS DISCOVERED LOOSE DURING THE INSERTION OF THE GUIDEWIRE. THE ENDOTRACHEAL TUBE WAS REPLACED, AND AFTER A THOROUGH INSPECTION CONFIRMING NO LOOSENESS, THE INTUBATION OPERATION WAS PERFORMED, WHICH DID NOT CAUSE ADVERSE CONSEQUENCES TO THE INFANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22536554 ↗
• MalfunctionApr 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PREPARATION FOR INTUBATION OF A BABY USING A 3.0 TRACHEAL TUBE, THE HUB OF THE TUBE BROKE, RENDERING IT UNUSABLE. THE RESPIRATORY THERAPIST REMOVED THE HUB TO TRIM THE TUBE'S LENGTH AND THEN REPLACED THE TUBE ON THE HUB. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885129 ↗
• MalfunctionApr 21, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING THE INTUBATION PROCEDURE OF A PREMATURE PATIENT, THE ENDOTRACHEAL TUBE WAS FOUND TO BE VERY FLEXIBLE, MAKING THE PROCEDURE DIFFICULT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21874491 ↗
• MalfunctionApr 17, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MARKING OF THE ENDOTRACHEAL TUBE FADED OFF AFTER THREE DAYS OF INTUBATION. USED MARKERS AND REARRANGE THE TUBE TO OVER RIGHT THE FADED MARKINGS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861009 ↗
• MalfunctionDec 10, 2024Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT AT A HOSPITAL, THERE WAS A MALFUNCTION INVOLVING THE ENDOTRACHEAL TUBE, SPECIFICALLY THE BREAKAGE OF THE PILOT LINE AND A BROKEN TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20889118 ↗
• MalfunctionSep 18, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE POUCH WAS OPENED, IT WAS NOTICED BY DECOUPLING, THAT THE TUBE HAS A NON-ROUTINE NOTCH. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20245415 ↗
• InjuryAug 22, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE VENTILATOR HAD A WARNING OF LOSS PIP AND IT WAS FOUND THAT THE ENDOTRACHEAL TUBE WAS DISCONNECTED FROM THE JET ADAPTER. AT AROUND 1230H, THE TUBE DISCONNECTED AGAIN. AFTER PUTTING IT BACK FROM "KCARE" AT 1445, THE TUBE WAS DISCONNECTED MORE THAN FOUR TIMES. BETWEEN 1500H AND 1600H, THE TUBE WAS DISCONNECTED SEVERAL MORE TIMES WHILE THE PATIENT SETTLED IN BED WITH THE TUBE SECURED AND APPROPRIATE BOUNDARIES IN PLACE. THE PATIENT DESATURATED INTO THE 40'S, THE RESPIRATORY BUTTON WAS PUSHED, AND THE TUBE WAS RECONNECTED TO THE VENTILATOR. THE PATIENT WENT TO 100% BUT THEN RECOVERED TO BASELINE. THE PATIENT WAS SWITCHED TO CONVENTIONAL VENTILATION TO PREVENT FURTHER DISCONNECTIONS OF THE ETT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20042869 ↗
• InjuryJul 8, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S DISTAL TIP INVERTED INTRATRACHEALLY DURING USE. THERE WAS A DELAY IN TREATMENT AND THE TUBE WAS REPLACED.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 19690740 ↗
• MalfunctionApr 19, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S DISTAL TIP BUCKLED DURING THE PROCEDURE. THE TUBE WAS REPLACED.

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

  MAUDE report 19143527 ↗
• MalfunctionApr 13, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE NUMBERS OR MARKING HAD WORN OFF, EVEN ABOVE WHERE THE ENDOTRACHEAL TUBE WAS TAPED DURING USE AND CAUSED UNPLANNED SELF-EXTUBATION. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19102631 ↗
• MalfunctionFeb 25, 2024Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, THE DISTAL TIP OF THE ENDOTRACHEAL TUBE BUCKLED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Insufficient Information

  MAUDE report 18775096 ↗
• InjuryAug 12, 2022Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING OXYGENATION OF THE NEWBORN, THE VENTILATOR INDICATED AN OVERPRESSURE AND UNABLE TO VENTILATE A NEWBORN THROUGH THE TUBE DESPITE ALL TECHNICAL CHECKS AND ELIMINATION OF ANY DIAGNOSIS THAT MIGHT EXPLAIN THESE DIFFICULTIES. THE TUBE WAS CHANGED TO SOLVED THE PROBLEM.

  Patient problems: Hypoxia; Unintended Extubation

  MAUDE report 15217793 ↗
• MalfunctionSep 29, 2021Connection Problem; Material Split, Cut or Torn; Connection Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD A BROKEN 15MM CONNECTOR, AND THERE WAS A HOLE ON THE TUBE. THE PATIENT WAS REINTUBATED WITH ANOTHER TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 12548269 ↗