Shiley 86451Recalls & reported problems
Covidien LP · Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye · Class 2
Quick summary
This Shiley Hi-Lo oral/nasal tracheal tube is a cuffed breathing tube used to secure the airway during surgery or ventilation. The 52 reports mostly describe the cuff failing to hold air, popping or rupturing inside the trachea, and small or undersized cuffs, along with air leaking from the tube and the cuff not inflating properly; several describe the tube coming out earlier than intended. Reports mention 5 deaths and 12 injuries. No recalls name this device.
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
- 55
- Deaths reported
- 5
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 30884522000479), received between Sep 13, 2017 and Sep 28, 2026 — classified as 5 deaths, 12 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (17 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
- Gas/Air Leak17
- Use of Device Problem12
- Connection Problem10
- Inflation Problem4
- Material Split, Cut or Torn4
- Defective Component2
- Insufficient Device Problem Information2
- Manufacturing, Packaging or Shipping Problem2
Patient problems
- Unintended Extubation21
- Insufficient Information16
- No Clinical Signs, Symptoms or Conditions9
- Extubate7
- No Known Impact Or Consequence To Patient4
- No Information3
- Death2
- Low Blood Pressure/ Hypotension2
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Gas/Air Leak
Patient problems: Insufficient Information
MAUDE report 50923422 ↗MalfunctionSep 23, 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 50867795 ↗MalfunctionSep 8, 2026Disconnection
Patient problems: Insufficient Information
MAUDE report 50667554 ↗MalfunctionMar 17, 2026Use of Device Problem; Gas/Air Leak
IT WAS REPORTED THAT PRIOR TO USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD A LEAK. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24624328 ↗InjuryJan 26, 2026Defective Component
IT WAS REPORTED THAT AN AUDIBLE LEAK WAS HEARD AND TIDAL VOLUMES WERE NOT BEING REACHED DUE TO A SMALLER CUFF SIZE OF THE ENDOTRACHEAL TUBE AS SHOWN FROM THE PHOTO PROVIDED. THE PATIENT DID RECEIVE A TUBE EXCHANGE LATER. WHEN COMPARED, IT WAS FOUND THAT THE AFFECTED TUBE¿S CUFF WAS SIGNIFICANTLY SMALLER AND ALMOST HALF THE SIZE AND THE AFFECTED TUBE SHOWED NO OBVIOUS LEAKS OR DEFECTS OTHER THAN THE CUFF BEING SMALLER.
Patient problems: Hypoventilation; Unintended Extubation
MAUDE report 24184892 ↗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 24059449 ↗MalfunctionDec 30, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT AFTER SUCCESSFUL INTUBATION WITH A 7.5 MILLIMETER TRACHEAL TUBE, AN AIR LEAK WAS OBSERVED. THERE WERE ISSUES WITH CUFF WOULD NOT HOLD AIR. THE PATIENT WAS EXTUBATED AND REINTUBATED WITH ANOTHER TUBE. EXAMINATION OF THE FIRST TUBE CONFIRMED THAT THE CUFF WOULD NOT HOLD AIR.
Patient problems: Unintended Extubation
MAUDE report 23926284 ↗MalfunctionDec 19, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING INTRA-OPERATIVE USE SIZE 7.5MM ENDOTRACHEAL TUBE, THE CUFF WAS OBSERVED TO BE POPPING WHILE IN THE TRACHEA. THE TUBE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23852076 ↗MalfunctionDec 12, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF WERE "RUPTURED" IN THE PATIENT'S TRACHEA. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23793989 ↗MalfunctionSep 3, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF WAS UNABLE TO MAINTAIN INFLATION AND KEPT DEFLATING. THE ISSUE WAS IDENTIFIED DURING USE AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956506 ↗MalfunctionApr 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING USE, THE TRACH LEAKED GAS FROM THE PATIENT'S MOUTH. TRACH WAS REPLACED AND THE THE LEAK WAS CEASED. UPON INSPECTION, THERE WAS A SMALL HOLE IN THE TRACH WHERE THE PILOT LINE BALLOON WAS CONNECTED.
Patient problems: Unintended Extubation
MAUDE report 21883930 ↗InjuryOct 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, THE PATIENT USING THE TUBE EXPERIENCED HYPER EXPANSION AND DEVELOPED RIGHT LOWER LOBE PNEUMONIA. THE PATIENT WAS FOUND OBTUNDED, AND RAPID SEQUENCE INTUBATION WAS PERFORMED. POST-INTUBATION, THE PATIENT EXPERIENCED HYPOTENSION AND WAS GIVEN A 1L BOLUS CRYSTALLOID AND PUSH DOSE EPINEPHRINE, WHICH IMPROVED THE PRESSURE. HOWEVER, POTASSIUM LEVELS SPIKED TO 6.0, AND ALBUTEROL WAS ADMINISTERED FOR AN HOUR. SUBSEQUENTLY, THE CUFF LEAKED, AND THE TUBE WAS DISLODGED DURING ICU ADMISSION. THE TUBE WAS REPLACED, BUT THE PATIENT EXPERIENCED POST-INTUBATION HYPOTENSION AGAIN AND PERIPHERAL NOREPINEPHRINE DROPS WAS STARTED.
Patient problems: Low Blood Pressure/ Hypotension; Overinflation of Lung; Pneumonia; Unintended Extubation
MAUDE report 20481907 ↗MalfunctionSep 30, 2024
MALFUNCTIONING ENDOTRACHEAL TUBE (ETT) IN THREE DIFFERENT PATIENTS ON SAME NIGHT SHIFT. PATIENTS WERE INTUBATED WITH THE ETT, AND AFTER PLACEMENT, A CUFF LEAK WAS IDENTIFIED IN EACH PATIENT.
Patient problems: Insufficient Information
MAUDE report 20333170 ↗MalfunctionSep 30, 2024
MALFUNCTION IN ENDOTRACHEAL TUBE (ETT) AFTER INTUBATION, CUFF LEAK SUSPECTED, AND DEVICE REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 20333143 ↗MalfunctionSep 30, 2024
PATIENT INTUBATED WITH #7.5 ENDOTRACHEAL TUBE (ETT) FOR RESPIRATORY FAILURE WITH ALTERED MENTAL STATUS AT [TIME REDACTED]. THE ETT DEVELOPED A CUFF LEAK AND PATIENT REQUIRED RE-INTUBATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20333112 ↗InjurySep 10, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE PATIENT WAS USING THE TUBE AND WAS MANUALLY VENTILATED AFTER A LEAK WAS FOUND IN THE CUFF. THE PATIENT'S PULSE OXYGENATION WAS AT 85% AND THE TUBE WAS REPLACED.
Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Unintended Extubation
MAUDE report 20186162 ↗MalfunctionSep 10, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S CUFF HAD LEAKS. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 20186089 ↗MalfunctionSep 10, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S CUFF HAD LEAKS. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 20186003 ↗MalfunctionAug 9, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE TWO ENDOTRACHEAL TUBES' PILOT BALLOON STRINGS SEEMED TO FALL OFF. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19947799 ↗MalfunctionApr 26, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE BALLOON OF THE ENDOTRACHEAL TUBE HAD A LEAK AND IT WAS FOUND DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19192771 ↗MalfunctionOct 31, 2023Connection Problem; Connection Problem
ACCORDING TO THE REPORTER, THE CONNECTOR OF AN ENDOTRACHEAL TUBE HAD GOTTEN MISALIGNED AND STUCK IN THE "BAVU", MAKING CONNECTION OF THE MECHANICAL VENTILATOR MACHINE TO THE INTUBATION TUBE DIFFICULT. EXPOSING THE PATIENT TO 60% DESATURATION.
Patient problems: Low Oxygen Saturation
MAUDE report 18044207 ↗MalfunctionMar 20, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S CUFF WAS FOUND BROKEN AND AND HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16576621 ↗MalfunctionMay 16, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING SURGERY, THE CUFF OF THE DEVICE FAILED. REINTUBATION WAS REQUIRED.
Patient problems: Unintended Extubation
MAUDE report 14408406 ↗MalfunctionMay 13, 2022Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING SURGERY, THE CUFF OF THE DEVICE FAILED. REINTUBATION WAS REQUIRED.
Patient problems: Unintended Extubation
MAUDE report 14398036 ↗MalfunctionOct 20, 2021Use of Device Problem; Manufacturing, Packaging or Shipping Problem; Use of Device Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE BALLOON HAD DIFFICULTY INFLATING AND DEFLATING TO THE POINT SOMETIMES NOT DEFLATED. THERE WAS NO PATIENT INJURY/HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12666142 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.