Shiley 18775Recalls & reported problems
Covidien LP · TaperGuard Oral/Nasal Tracheal Tube Murphy Eye · Class 2
Quick summary
This Covidien TaperGuard tracheal tube is a breathing tube placed in the windpipe to help a patient breathe. Its 491 reports most often describe air leaks, tube splits and the tube coming out unintentionally. Recent reports describe damage and cuff inflation problems found during pre-use checks. The reports include 33 injuries and no deaths. No recalls name this device. Reports fell from 102 the year before to 61 in the latest year.
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
- 489
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 489 adverse event reports that list this exact device (DI 10884522007603), received between Oct 4, 2017 and Sep 9, 2026 — classified as 33 injuries, 456 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (199 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 Leak199
- Use of Device Problem175
- Material Split, Cut or Torn72
- Connection Problem21
- Defective Component18
- Material Integrity Problem12
- Crack9
- Disconnection9
Patient problems
- Unintended Extubation235
- No Clinical Signs, Symptoms or Conditions221
- No Patient Involvement27
- Extubate19
- Insufficient Information7
- Low Oxygen Saturation5
- Hypoventilation4
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 25 most recent of 489 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699633 ↗MalfunctionSep 9, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699586 ↗MalfunctionSep 9, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699503 ↗MalfunctionAug 26, 2026Material Puncture/Hole; Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50464487 ↗MalfunctionAug 25, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50437809 ↗MalfunctionAug 25, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50437794 ↗MalfunctionJul 15, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 25833284 ↗MalfunctionJul 15, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25828022 ↗MalfunctionJun 23, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THERE WAS A SUSPICION THAT THERE WAS DAMAGE AT THE TUBE THAT CONNECTS BETWEEN THE PILOT LINE AND THE CUFF BOTH ENDOTRACHEAL TUBES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25593565 ↗MalfunctionJun 23, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THERE WAS A SUSPICION THAT THERE WAS DAMAGE AT THE TUBE THAT CONNECTS BETWEEN THE PILOT LINE AND THE CUFF BOTH ENDOTRACHEAL TUBES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25593550 ↗MalfunctionJun 4, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE TWO ENDOTRACHEAL TUBE'S CUFF HAD AIR LEAKAGE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25400000 ↗MalfunctionJun 4, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE TWO ENDOTRACHEAL TUBE'S CUFF HAD AIR LEAKAGE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399933 ↗MalfunctionJun 4, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25398998 ↗MalfunctionJun 4, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25398882 ↗MalfunctionJun 2, 2026Gas/Air Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAK. THE TUBE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 25365821 ↗MalfunctionMay 13, 2026Use of Device Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF FAILED TO INFLATE AT A HOSPITAL PRIOR TO USE. THE EVENT WAS ASSOCIATED WITH A PATIENT, AND THERE WAS NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166811 ↗MalfunctionMay 7, 2026Gas/Air Leak
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE CUFF OF THE ENDOTRACHEAL TUBE HAD A LEAK. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 25113106 ↗MalfunctionMay 7, 2026Gas/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 25112134 ↗MalfunctionApr 17, 2026Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S PILOT LINE BROKE OFF FROM THE PILOT BALLOON, AS SHOWN IN THE ATTACHED IMAGE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24912153 ↗MalfunctionApr 16, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT PRIOR TO USAGE, THE ENDOTRACHEAL TUBE'S CUFF WAS FOUND TEAR. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24904869 ↗MalfunctionMar 31, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THREE ENDOTRACHEAL TUBE'S CUFF HAD WATER LEAKAGE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24745075 ↗MalfunctionMar 31, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THREE ENDOTRACHEAL TUBE'S CUFF HAD WATER LEAKAGE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24745057 ↗MalfunctionMar 31, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THREE ENDOTRACHEAL TUBE'S CUFF HAD WATER LEAKAGE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744981 ↗MalfunctionMar 12, 2026Gas/Air Leak
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE CUFFS OF THE TWO ENDOTRACHEAL TUBES HAD AN AIR LEAK. REPLACEMENT OF THE TUBES WERE DONE.
Patient problems: Unintended Extubation
MAUDE report 24583401 ↗MalfunctionMar 12, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USE TESTING OF THE ENDOTRACHEAL TUBE IN A HOSPITAL SETTING. THE CUFF WAS TESTED PRIOR TO USE WITH A SYRINGE FOR INFLATION AND DEFLATION, BUT THE TEST WAS NOT SUCCESSFUL. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583279 ↗
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 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
- Portex 100/199/075Icu Medical, Inc. · Tube, tracheal (w/wo connector)4 deaths222 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.