TaperGuard 18780SRecalls & reported problems
Covidien LP · Tracheal Tube with Stylet Murphy Eye · Class 2
All models of TaperGuard (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien TaperGuard tracheal tube is a breathing tube with a stylet used to secure a patient's airway during surgery or ventilation. The 65 reports mostly describe cuff and air leak problems — leaks before or during use, holes or cracks in the cuff or tube, inflation line damage, and connectors coming loose or breaking — along with tubes coming out of patients unexpectedly. There are no deaths and 20 injuries. No recalls name this device, and reports have slowed sharply in the past 12 months, from 8 to 0.
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
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10884521103863), received between Mar 31, 2017 and Sep 11, 2025 — classified as 20 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (22 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 Problem22
- Gas/Air Leak17
- Material Split, Cut or Torn11
- Inflation Problem4
- Defective Component3
- Disconnection3
- Deflation Problem2
- Leak/Splash2
Patient problems
- Unintended Extubation26
- No Clinical Signs, Symptoms or Conditions20
- Extubate18
- No Patient Involvement4
- Insufficient Information2
- No Code Available2
- No Consequences Or Impact To Patient2
- Hypoventilation1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S CUFF FAILED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23025581 ↗MalfunctionAug 13, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT AIR WAS LEAKING FROM THE CUFF OF THE ENDOTRACHEAL TUBE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22800929 ↗MalfunctionAug 8, 2025Crack; Crack
IT WAS REPORTED THAT, PRIOR TO USAGE, IT WAS FOUND THAT THE 15MM CONNECTOR WAS DAMAGED CONNECTING TO THE TUBE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751645 ↗MalfunctionFeb 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE ALARM SOUNDED, SO WHEN THE NURSE WENT TO THE ROOM, THE INTUBATION TUBE HAD COME OUT OF THE PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 21300456 ↗MalfunctionJan 29, 2025Defective Component; Defective Component
IT WAS REPORTED THAT DURING REPLACEMENT, A HOLE WAS FOUND FROM EACH OF THE TWO ENDOTRACHEAL TUBE'S CUFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21263621 ↗MalfunctionJan 29, 2025Defective Component; Defective Component
IT WAS REPORTED THAT DURING REPLACEMENT, A HOLE WAS FOUND FROM EACH OF THE TWO ENDOTRACHEAL TUBE'S CUFF. THE TUBE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 21263600 ↗InjuryDec 9, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE HYPOVENTILATION ALARM SOUNDED BUT THERE WAS NO DROP IN SPO2, AND UPON CHECKING, THE INFLATION LINE WAS FOUND TO BE DAMAGED. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Hypoventilation; Unintended Extubation
MAUDE report 20888110 ↗MalfunctionNov 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING ROBOTIC SURGERY, A SUDDEN LEAK OCCURRED. UPON REMOVING THE TUBE, A CRACK WAS FOUND FROM THE MURPHY EYE TOWARD THE TUBE TIP. THE TUBE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 20802960 ↗MalfunctionAug 21, 2024Partial Blockage; Partial Blockage
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE WAS USED THE SAME AS USUAL, BUT VENTILATION WAS DIFFICULT. THE REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 20010246 ↗MalfunctionMar 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF BROKE DURING INTUBATION. IT WAS UNCERTAIN IF THE CUFF HIT THE PATIENT'S TEETH OR OVER INFLATED AS SHOWN IN THE PHOTOS. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 19001074 ↗MalfunctionMar 28, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE PATIENT WENT INTUBATED FROM THE EMERGENCY ROOM TO THE INTENSIVE CARE UNIT, WHERE A LEAKY CUFF WAS FOUND AND HAD TO REINTUBATE THE PATIENT URGENTLY.
Patient problems: Unintended Extubation
MAUDE report 19000435 ↗MalfunctionMar 26, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD INFLATION AND DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18979247 ↗MalfunctionMar 26, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD INFLATION AND DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18979024 ↗MalfunctionMar 22, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF HAD INFLATION OR DEFLATION ISSUE DURING THE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18963878 ↗MalfunctionFeb 16, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE VENTILATOR'S "INHALATION FLOW UNDETECTED" ALARM FREQUENTLY, BUT NO PROBLEM WAS FOUND. WHEN THE ENDOTRACHEAL TUBE'S CUFF PRESSURE WAS CHECKED, IT WAS 20CMH2O LOWER EVEN AFTER ADJUSTED PRESSURE. THE TUBE WAS REPLACED, AND CONFIRMED THAT THERE WERE NO MORE ALARMS OR CUFF PRESSURE DROPS. UPON CHECKING THE EXTUBATED TUBE, THERE WERE NO CUFF TEARS, BUT AIR WOULD COME OUT WHEN THE CUFF WAS CRUSHED BY HAND.
Patient problems: Unintended Extubation
MAUDE report 18727015 ↗MalfunctionJan 30, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF DID NOT INFLATE DURING PATIENT USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 18608614 ↗MalfunctionJan 3, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF WAS NOT INFLATING AND GRADUALLY LEAKED AIR DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18437664 ↗MalfunctionOct 23, 2023Obstruction of Flow; Gas/Air Leak; Obstruction of Flow; Gas/Air Leak
ACCORDING TO THE REPORTER, THERE WAS A SOUND LIKE SPUTUM RETENTION IN THE ENDOTRACHEAL TUBE. THE CUFF PRESSURE WAS CHECKED AND FOUND TO BE ABOUT 10 CMH2O. THE CUFF WAS INFLATED TO 30 CM H2, BUT AFTER 1 MINUTE, THE SOUND LIKE SPUTUM RETENTION WAS HEARD AGAIN. WHEN THE CATHETER PRESSURE WAS CHECKED AGAIN, THE CATHETER PRESSURE DECREASED TO 10 CMH2O, SO THE INTUBATION TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 17988110 ↗MalfunctionJul 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE WAS DAMAGED AND HAD A LEAK AFTER FIVE DAYS OF USE. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 17281380 ↗MalfunctionJun 1, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17042828 ↗MalfunctionMay 25, 2023Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE AIR IN THE CUFF OF THE ENDOTRACHEAL TUBE WAS UNABLE TO BE REMOVED DURING PROCEDURE. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 17002191 ↗MalfunctionApr 20, 2023Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE DURING THE PROCEDURE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 16779161 ↗MalfunctionMar 23, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS TORN PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16600126 ↗MalfunctionDec 14, 2022Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE CUFF WAS PRE-TESTED AND DID NOT DEFLATE. AN AIR LEAK WAS FOUND AFTER INTUBATION AND THOUGHT TO BE AN AIR LEAKED FROM THE CUFF. THE DEVICE WAS REMOVED AND CHECKED, BUT THERE WERE NO PROBLEMS FOUND ON THE CUFF. THE PATIENT HAD A REPLACEMENT OF THE TUBE.
Patient problems: Unintended Extubation
MAUDE report 15982368 ↗MalfunctionDec 6, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE CUFF WAS PRE-INSPECTED AND IT WAS FOUND THAT THERE WAS INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15927544 ↗
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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