Shiley 18880SRecalls & reported problems
Covidien LP · TaperGuard Evac Oral Tracheal Tube with Stylet Murphy Eye · Class 2
All models of Shiley (387)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Shiley TaperGuard oral tracheal tube is a breathing tube with a stylet and cuff used to secure the airway. Most of the 66 reports describe the cuff leaking air or being torn or split, sometimes noticed before or during use, and tubes coming out of place sooner than intended. There are no deaths and 6 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
- 65
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10884521726710), received between May 7, 2020 and Aug 11, 2026 — classified as 6 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (29 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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem29
- Gas/Air Leak14
- Material Split, Cut or Torn14
- Connection Problem3
- Disconnection3
- Material Separation3
- Obstruction of Flow3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- Unintended Extubation25
- Insufficient Information3
- Airway Obstruction2
- Dyspnea2
- Obstruction/Occlusion2
- Aspiration/Inhalation1
- Extubate1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208107 ↗MalfunctionApr 22, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING USE, THE TWO ENDOTRACHEAL TUBE'S CUFF WERE FOUND DAMAGED. THE TUBES WERE REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24956595 ↗MalfunctionApr 22, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING USE, THE TWO ENDOTRACHEAL TUBE'S CUFF WERE FOUND DAMAGED. THE TUBES WERE REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24956547 ↗MalfunctionMar 3, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE WAS SET IN THE AWS (AIRWAY SCOPE) GUIDE, IT WAS FOUND THAT THE CUFF WAS DAMAGED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498192 ↗MalfunctionFeb 26, 2026Use of Device Problem
IT WAS REPORTED THAT PRIOR TO USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD AN AIR LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457028 ↗MalfunctionJan 21, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT PRIOR TO USAGE, THE ENDOTRACHEAL TUBE'S CUFF WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24134819 ↗MalfunctionJan 7, 2026Use of Device Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF "RUPTURED" DURING THE CUFF CHECK. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23998482 ↗MalfunctionDec 5, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD A LEAK. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 23726766 ↗MalfunctionDec 5, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD A LEAK. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 23726730 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF WAS DIFFICULT TO INFLATE AND DEFLATE WHEN INSPECTED BEFORE USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018963 ↗MalfunctionSep 9, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING CUFF CHECK, THE CUFF FAILED TO EXPAND AND IT COULD NOT BE DEFLATED AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23000475 ↗MalfunctionSep 3, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT INFLATE/DEFLATE NORMALLY DURING THE PRE-USAGE INSPECTION. IT WAS ALSO STATED THAT MORE RESISTANCE WAS FELT COMPARED TO OTHER TUBES, AND IT WAS DIFFICULT TO INFLATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960151 ↗MalfunctionJun 9, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT INFLATE DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22171144 ↗MalfunctionJun 3, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CUFF PRESSURE WAS LEAKED, AIR CAME OUT BEFORE IT WAS NOTICED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 22131334 ↗MalfunctionJun 2, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak
IT WAS REPORTED THAT AFTER INTUBATION, THERE WAS VOCALIZATION, AND UPON CHECKING, THE CUFF PRESSURE DID NOT INCREASE. THERE WAS ALSO CONCERN ABOUT CUFF "RUPTURE" OR VALVE MALFUNCTION. REPLACEMENT OF THE TUBE WAS DONE. UPON CHECKING AFTER EXTUBATION, THE CUFF INFLATED WITH AIR BUT DEFLATED NATURALLY.
Patient problems: Unintended Extubation
MAUDE report 22126236 ↗MalfunctionMay 22, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE TESTING INSIDE A DOCTOR HELICOPTER, THE ENDOTRACHEAL TUBE'S CUFF WAS NOT INFLATING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22071349 ↗MalfunctionMay 22, 2025Component Missing; Defective Device; Component Missing; Defective Device
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S STYLET WAS MISSING PRIOR TO USE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22070407 ↗MalfunctionMay 20, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD A LEAK PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054999 ↗MalfunctionApr 24, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PRE-TESTING, THE ENDOTRACHEAL TUBE'S CUFF HAD RESISTANCE IN THE AIR IN AND OUT (INFLATION AND DEFLATION), AND IT WAS REPLACED WITH ANOTHER TUBE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21902001 ↗MalfunctionApr 22, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT AT THE EMERGENCY OUTPATIENT ROOM, A LEAK SOUND WAS HEARD FROM THE MOUTH AFTER INTUBATION. AIR WAS PUMPED INTO THE ENDOTRACHEAL TUBE'S CUFF, BUT IT STILL SEEMED TO BE LEAKING. THE INTUBATION TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 21885007 ↗MalfunctionApr 21, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT AFTER THE ENDOTRACHEAL TUBE WAS INTUBATED TO THE PATIENT, THE CUFF HAD A CONTINUOUS LEAK. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 21872722 ↗MalfunctionMar 28, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING USE, AN ENDOTRACHEAL TUBE'S CUFF LEAKAGE WAS NOTICED AND THE PATIENT WAS EXTUBATED. THE CUFF WAS CHECKED FOR PINHOLES BY IMMERSING IT IN WATER, AND A PINHOLE WAS FOUND NEAR THE BASE OF THE CUFF.
Patient problems: Unintended Extubation
MAUDE report 21727285 ↗MalfunctionMar 20, 2025Decoupling; Material Split, Cut or Torn; Decoupling; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CONNECTION PART OF THE UPPER CUFF SUCTION LINE (YELLOW PART) GOT DETACHED EASILY FROM THE SUCTION LINE. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 21656630 ↗MalfunctionMar 19, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PRE-TESTING, THE ENDOTRACHEAL TUBE'S CUFF WAS FOUND NOT INFLATING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21644130 ↗MalfunctionFeb 19, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE SLIP JOINT OF THE ENDOTRACHEAL TUBE FELL OFF, AND ALTHOUGH IT WAS PUT BACK ON THE TUBE, IT KEPT COMING OFF REPEATEDLY. THE SLIP JOINT WAS ATTACHED AND SECURED WITH A STRING. RE-INTUBATION WAS PERFORMED THE NEXT DAY DURING THE DAYTIME, AND IT WAS FIXATED AT 22CM.
Patient problems: Unintended Extubation
MAUDE report 21407506 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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