Shiley 87475Recalls & reported problems
Covidien LP · Oral/Nasal Endotracheal Tube, Intermediate Cuff Non DEHP · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Shiley endotracheal tube is used to support breathing during anesthesia and ventilation. Reports mostly describe air leaks around the cuff or connections, parts coming apart, and unintended tube removal. There are 42 adverse event reports naming its identifier, including 2 deaths and 4 injuries. No recalls name this device; reports increased from 15 in the previous 12 months to 23 in the latest 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
- 40
- Deaths reported
- 2
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10884521815278), received between Sep 5, 2024 and Sep 27, 2026 — classified as 2 deaths, 4 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (14 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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem14
- Gas/Air Leak13
- Disconnection4
- Connection Problem3
- Defective Component3
- Physical Resistance/Sticking3
- Material Deformation2
- Material Split, Cut or Torn2
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Unintended Extubation17
- Insufficient Information5
- Low Oxygen Saturation2
- Hypoventilation1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910488 ↗MalfunctionJul 30, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50085992 ↗MalfunctionJul 28, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50061141 ↗MalfunctionJul 28, 2026Gas/Air Leak
Patient problems: Insufficient Information
MAUDE report 50061003 ↗MalfunctionJun 23, 2026Gas/Air Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT AN ENDOTRACHEAL TUBE WAS ASSOCIATED WITH AN EVENT IN A HOSPITAL SETTING WHERE THE CUFF WAS FOUND TO BE BROKEN DURING USE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 25590590 ↗MalfunctionJun 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT WHEN THE PATIENT ANAESTHETIZED AND INTUBATED WITH DEVICE. A 10MM SPLIT FROM THE 15MM CONNECTOR WAS NOTED. TUBE HAD NOT BEEN CUT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25531897 ↗MalfunctionJun 8, 2026Gas/Air Leak
IT WAS REPORTED THAT ORAL ENDOTRACHEAL INTUBATION WAS IMMEDIATELY PERFORMED DUE TO A CHANGE IN CONDITION AND THE PATIENT WAS CONNECTED TO A VENTILATOR FOR ASSISTED VENTILATION. THE BEDSIDE NURSE NOTICED AN AIR-LEAK SOUND FROM THE PATIENT¿S THROAT. AFTER INFLATING THE CUFF, THE SEAL WAS MAINTAINED FOR SEVERAL MINUTES BUT LEAKAGE RECURRED. THE TUBE WAS REPLACED. AFTER REMOVAL, INSPECTION OF THE TUBE SHOWED THAT THE CUFF SLOWLY LEAKED AFTER INFLATION, RESULTING IN INSUFFICIENT CUFF PRESSURE.
Patient problems: Unintended Extubation
MAUDE report 25429089 ↗MalfunctionMay 21, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THERE WAS A HOLE IN THE SIDE OF THE ENDOTRACHEAL TUBE, LOCATED AT THE ENTRY POINT OF THE PILOT BALLOON. THERE WAS A DIVOT ON ALL THE TUBES AT THIS POINT, THE ONE USED HAD A HOLE INSTEAD OF A DIVOT AND THE PATIENT COULD NOT BE VENTILATED PROPERLY. TUBE HAD TO BE CHANGED FOR ANOTHER THAT LOOKED SUSPICIOUSLY LIKE IT ALSO HAD A LEAK, AS DID THE THIRD. ANOTHER DIFFERENTLY BRANDED TUBE WAS USED INSTEAD WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241244 ↗MalfunctionMay 21, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THERE WAS A HOLE IN THE SIDE OF THE ENDOTRACHEAL TUBE, LOCATED AT THE ENTRY POINT OF THE PILOT BALLOON. THERE WAS A DIVOT ON ALL THE TUBES AT THIS POINT, THE ONE USED HAD A HOLE INSTEAD OF A DIVOT AND THE PATIENT COULD NOT BE VENTILATED PROPERLY. TUBE HAD TO BE CHANGED FOR ANOTHER THAT LOOKED SUSPICIOUSLY LIKE IT ALSO HAD A LEAK, AS DID THE THIRD. ANOTHER DIFFERENTLY BRANDED TUBE WAS USED INSTEAD WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241235 ↗MalfunctionMay 21, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THERE WAS A HOLE IN THE SIDE OF THE ENDOTRACHEAL TUBE, LOCATED AT THE ENTRY POINT OF THE PILOT BALLOON. THERE WAS A DIVOT ON ALL THE TUBES AT THIS POINT, THE ONE USED HAD A HOLE INSTEAD OF A DIVOT AND THE PATIENT COULD NOT BE VENTILATED PROPERLY. TUBE HAD TO BE CHANGED FOR ANOTHER THAT LOOKED SUSPICIOUSLY LIKE IT ALSO HAD A LEAK, AS DID THE THIRD. ANOTHER DIFFERENTLY BRANDED TUBE WAS USED INSTEAD WITHOUT INCIDENT.
Patient problems: Unintended Extubation
MAUDE report 25241175 ↗MalfunctionApr 23, 2026Use of Device Problem; Material Deformation
IT WAS REPORTED THAT DURING USE, THE CUFF'S INFLATION LINE OF THE ENDOTRACHEAL TUBE WAS KINKED. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 24968123 ↗MalfunctionMar 23, 2026Use of Device Problem; Material Deformation
IT WAS REPORTED THAT IN A HOSPITAL SETTING, THE ENDOTRACHEAL TUBE FOLDED AT THE POINT WHERE THE CUFF INFLATION LINE WAS INSERTED, AND THE INFLATION LINE WAS SEVERED AFTER A DURATION OF PLACEMENT OF 29 DAYS. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24669703 ↗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 24628312 ↗MalfunctionFeb 26, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE OF THE ENDOTRACHEAL TUBE IN A HOSPITAL SETTING, THE TUBE LEAKS AROUND THE CUFF DESPITE BEING DEEP ENOUGH AND INFLATED, AND LOSES CUFF PRESSURE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 24457987 ↗MalfunctionFeb 13, 2026Gas/Air Leak
IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS LEAKING AT A HOSPITAL. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24337222 ↗MalfunctionJan 28, 2026Use of Device Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE EXPERIENCED A CUFF INFLATION AND DEFLATION ISSUE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24206270 ↗MalfunctionJan 7, 2026Human-Device Interface Problem
IT WAS REPORTED THAT THE CUFF INFLATION TUBE OF THE ENDOTRACHEAL TUBE WAS POSITIONED TOO FAR INSIDE THE MOUTH ABOUT 16 CM INSTEAD OF 21 CM UNLIKE WITH THE OTHER TUBE. WHEN A PATIENT WOKE UP, THE PATIENT'S TEETH CUT THE CUFF INFLATION TUBE, AND THE PATIENT WAS REQUIRED TO BE PUT BACK TO SLEEP AFTER THE TUBE WAS CUT. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 23999714 ↗DeathDec 23, 2025Defective Component; Defective Component
IT WAS REPORTED THAT DURING INTUBATION WITH TWO ENDOTRACHEAL TUBES INVOLVED, THE PATIENT DIED. ALLEGATIONS INCLUDED THAT THE ENDOTRACHEAL TUBES HAD SLOW PUNCTURES AND THE CUFFS WERE DEFLATING WHILE THE PATIENT WAS INTUBATED.
Patient problems: Insufficient Information
MAUDE report 23881817 ↗DeathDec 23, 2025Defective Component; Defective Component
IT WAS REPORTED THAT DURING INTUBATION WITH TWO ENDOTRACHEAL TUBES INVOLVED, THE PATIENT DIED. ALLEGATIONS INCLUDED THAT THE ENDOTRACHEAL TUBES HAD SLOW PUNCTURES AND THE CUFFS WERE DEFLATING WHILE THE PATIENT WAS INTUBATED.
Patient problems: Insufficient Information
MAUDE report 23881797 ↗MalfunctionDec 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE PATIENT UNDERWENT FIRST ATTEMPTED ENDOTRACHEAL INTUBATION, AT THE TIME OF INTUBATION THE OUTER CUFF PORTION DID NOT ENCAPSULATE THE AIR SO IT WAS LOSING PRESSURE. THE PATIENT DID NOT EXPERIENCE ANY RESPIRATORY DISTRESS; THE ERROR WAS OBSERVED ON THE ANESTHESIA MACHINE AND WAS CORRECTED IMMEDIATELY. THE DOCTOR MANEUVERS AND PERFORMED A SECOND INTUBATION ATTEMPT WHICH WAS SUCCESSFUL AND STABILIZES THE PATIENT.
Patient problems: Unintended Extubation
MAUDE report 23782954 ↗MalfunctionNov 5, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT IN A HOSPITAL SETTING, THE ENDOTRACHEAL TUBE'S CUFFS WOULD NOT STAY INFLATED AFTER INSERTION. THE TUBE WAS REMOVED AND REPLACED, BUT THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Unintended Extubation
MAUDE report 23479974 ↗MalfunctionOct 20, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S CUFF WAS FAULTY, HAVING A SLOW LEAK AND WOULD NOT HOLD PRESSURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23338409 ↗MalfunctionSep 18, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A CUFF LEAK WAS DETECTED WITH THE ENDOTRACHEAL TUBE DURING TEST BEFORE USE AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23089527 ↗MalfunctionSep 2, 2025Defective Component; Device Markings/Labelling Problem; Defective Component; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD FADED LENGTH MARKINGS AND A SIGNIFICANT DIFFERENCE IN LENGTH AND PLACEMENT OF MARKERS ON TUBES FROM THE SAME BATCH. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22945896 ↗MalfunctionAug 22, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE ENDOTRACHEAL TUBE'S CUFF HAD A LEAK. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873914 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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