Shiley 87470Recalls & reported problems
Covidien LP · Oral/Nasal Endotracheal Tube, Intermediate Cuff Non DEHP · Class 2
All models of Shiley (387)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Shiley 87470 oral/nasal endotracheal tube is a breathing tube used during surgery and emergency care. The 47 reports mostly describe the cuff leaking air or failing to inflate and deflate, the connector coming apart, and the tube material splitting, peeling or deforming, sometimes leaving the tube kinked after it was already in place. One report describes the tube coming out of the patient unexpectedly; one injury was reported and no deaths. No recalls name this device, and the 12-month report count is close to the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10884521815261), received between Jan 30, 2025 and Sep 25, 2026 — classified as 2 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (28 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem28
- Gas/Air Leak5
- Material Deformation4
- Material Split, Cut or Torn4
- Defective Component2
- Device Markings/Labelling Problem2
- Failure to Seal2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Unintended Extubation10
- Hypoventilation1
- Insufficient Information1
- Laceration(s)1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Material Deformation
Patient problems: Hypoventilation; Unintended Extubation
MAUDE report 50904161 ↗MalfunctionAug 25, 2026Disconnection
It was reported that during use of the endotracheal tube, the patient was positioned from supine to prone for a spine surgery and immediately noted the universal 15mm connector removed from the tube. Additional staff had to be called into the rooms in order to reposition patient and reconnect back the tube each time. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50437715 ↗MalfunctionAug 11, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50203342 ↗MalfunctionJul 31, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100340 ↗MalfunctionJul 31, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098302 ↗MalfunctionJul 29, 2026Use of Device Problem; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50074338 ↗MalfunctionJun 12, 2026Nonstandard Device; Material Deformation
IT WAS REPORTED THAT THE PATIENT WAS INTUBATED WITH THE ENDOTRACHEAL TUBE FOR THE HIATUS HERNIA PROCEDURE WITH NO ISSUES FROM THE ANESTHETIC ROOM, CUFF HERNIATION OCCURRED AFTER TRANSFER TO THEATRE. TUBE ADVANCED UNDER A VIDEO LARYNGOSCOPE GUIDANCE AND SECURED. THE AIRWAY PRESSURE ALARM WAS RAISED, NO WHEEZE, BILATERAL AIR ENTRY, THE SUCTION CATHETER UNABLE NOT PASS DOWN THE TUBE, PHYSICAL CHECK (FINGER SLID DOWN PATH OF TUBE) REVEALED KINK IN TUBE AT BACK OF TONGUE. THE TUBE WAS REPLACED FROM OTHER MANUFACTURER.
Patient problems: Unintended Extubation
MAUDE report 25484815 ↗MalfunctionJun 1, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S PEELED OFF IN A HOSPITAL SETTING WHEN XYLOCAINE 10% SPRAY WAS USED. THE PRODUCT WAS REPLACED WITH A NEW ONE OF THE SAME TYPE, AND THE LIP MARK DID NOT PEEL OFF. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25352247 ↗MalfunctionMay 15, 2026Use of Device Problem; Failure to Seal
IT WAS REPORTED THAT POST-OPERATIVELY, ONE ENDOTRACHEAL TUBE'S CUFF DID NOT HOLD AIR OR CREATE A SEAL WAS OBSERVED. THE SECOND TUBE SAME ISSUE WAS OBSERVED DURING PRE-USAGE INSPECTION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25186168 ↗MalfunctionMay 15, 2026Use of Device Problem; Gas/Air Leak; Failure to Seal
IT WAS REPORTED THAT POST-OPERATIVELY, ONE ENDOTRACHEAL TUBE'S CUFF DID NOT HOLD AIR OR CREATE A SEAL WAS OBSERVED. THE SECOND TUBE SAME ISSUE WAS OBSERVED DURING PRE-USAGE INSPECTION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185979 ↗MalfunctionMay 13, 2026Material Deformation
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE SUCTION TUBE COULD NOT BE INSERTED INTO THE TUBE BECAUSE OF A DENT. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 25162020 ↗MalfunctionMar 18, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF WAS INFLATED BUT DEFLATED SLOWLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24628269 ↗MalfunctionMar 9, 2026Material Deformation
IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE WAS DEFORMED IN COMPLETELY DIFFERENT ANGLE THAT CAUSED A LEAKAGE FROM THE VENTILATOR. IT WAS ALSO OBSERVED THAT THE TUBE WAS SLIPPING UPWARDS IN BETWEEN AND ABOVE THE VOCAL CORDS, THOUGH THE DEPTH OF THE TUBE WAS CORRECT FROM THE MARKERS ON THE TUBE. THE TUBE WAS REPLACED.
Patient problems: Insufficient Information; Unintended Extubation
MAUDE report 24548315 ↗MalfunctionMar 5, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USE TESTING OF THE ENDOTRACHEAL TUBE THERE WAS AN INABILITY TO INFLATE OR DEFLATE THE CUFF. THE ISSUE WAS IDENTIFIED IN THE HOSPITAL AND THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24522673 ↗MalfunctionMar 2, 2026Use of Device Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF LOST PRESSURE AFTER A SHORT TIME IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490406 ↗MalfunctionMar 2, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USE TESTING OF THE ENDOTRACHEAL TUBE THERE WAS AN INABILITY TO INFLATE OR DEFLATE THE CUFF. THE ISSUE WAS IDENTIFIED IN THE HOSPITAL AND THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490391 ↗MalfunctionFeb 19, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE INK FROM THE VOCAL CORD MARKINGS ON THE ENDOTRACHEAL TUBE WAS DISCOVERED TO BE SMUDGED AND INK MARKS APPEARED ON THE INSIDE OF THE PACKAGING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389024 ↗MalfunctionDec 29, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT IT WAS DIFFICULT TO INJECT AIR INTO THE ENDOTRACHEAL TUBE'S CUFF DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23907488 ↗MalfunctionDec 16, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE WAS REMOVED, SALINE WAS INJECTED INTO THE CUFF, AND IT WAS FOUND TO BE LEAKING WATER AND DAMAGED. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23822306 ↗MalfunctionDec 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF DEFLATED DURING THE PROCEDURE. THE TUBE WAS REMOVED AND REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23779374 ↗MalfunctionNov 26, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE EXPERIENCED A CUFF INFLATION AND DEFLATION ISSUE PRIOR TO USE, AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23662372 ↗MalfunctionNov 17, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE FIRST ENDOTRACHEAL TUBE HAD CUFF INFLATION AND DEFLATION ISSUE. WHILE, OTHER TWO ENDOTRACHEAL TUBES HAD CUFF DIMENSIONAL ISSUE. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 23576432 ↗InjuryNov 12, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD DIMENSIONAL ISSUE THAT CAUSED LACERATION OF THE POSTERIOR WALL OF THE TRACHEA OF THE PATIENT.
Patient problems: Laceration(s); Unintended Extubation
MAUDE report 23532744 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S PILOT VALVE FELT LOOSE LEADING TO THE SYRINGE NOT STAYING PROPERLY ATTACHED, LEADING TO THE STAFF HAVING TO ADD PRESSURE SEVERAL TIMES DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019133 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S PILOT VALVE FELT LOOSE LEADING TO THE SYRINGE NOT STAYING PROPERLY ATTACHED, LEADING TO THE STAFF HAVING TO ADD PRESSURE SEVERAL TIMES DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019114 ↗
Other Tube, tracheal (w/wo connector) devices
- Shiley 18875Covidien LP · Tube, tracheal (w/wo connector)4 deaths570 reports
- RUSCH IPN041476Teleflex Incorporated · Tube, tracheal (w/wo connector)10 recalls0 reports
- Shiley 18775Covidien LP · Tube, tracheal (w/wo connector)489 reports
- Shiley 18770Covidien LP · Tube, tracheal (w/wo connector)2 deaths434 reports
- Shiley 18880Covidien LP · Tube, tracheal (w/wo connector)2 deaths370 reports
- Shiley 18780Covidien LP · Tube, tracheal (w/wo connector)3 deaths286 reports
- Shiley 18770SCovidien LP · Tube, tracheal (w/wo connector)273 reports
- Shiley 18780SCovidien LP · Tube, tracheal (w/wo connector)251 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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