TaperGuard 18770SRecalls & reported problems
Covidien LP · Tracheal Tube with Stylet Murphy Eye · Class 2
Quick summary
This Covidien TaperGuard 18770S is a tracheal tube with a stylet, used to keep a patient's airway open during ventilation. The 39 reports mostly describe air leaking from the cuff or pilot balloon and parts such as connectors coming loose or cracking, sometimes before use and sometimes during intubation, with a few reports of the tube coming out unexpectedly. Four reports involve injuries and no deaths. 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
- 39
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10884521103849), received between Mar 24, 2017 and Dec 13, 2024 — classified as 4 injuries, 35 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 Leak8
- Defective Component5
- Disconnection4
- Inflation Problem4
- Air Leak3
- Crack2
- Deflation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Patient Involvement11
- Unintended Extubation11
- Extubate4
- Insufficient Information3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Crack; Crack
ACCORDING TO THE REPORTER, PRIOR TO USAGE, THERE WAS A CRACK FOUND FROM THE ENDOTRACHEAL TUBE'S CONNECTOR INSERTION POINT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20924307 ↗MalfunctionSep 20, 2024Disconnection; Disconnection
ACCORDING TO THE REPORTER, THE CONNECTOR OF THE ENDOTRACHEAL TUBE CAME OFF SEVERAL TIMES. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20273807 ↗MalfunctionAug 14, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE ENDOTRACHEAL TUBE LEAKED AIR AND WAS UNABLE TO INJECT AND REMOVED AIR IN THE PILOT BALLOON. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 19981270 ↗MalfunctionAug 13, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ENDOTRACHEAL TUBE'S CUFF DEFLATED WHEN AIR WAS INJECTED DURING PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19972810 ↗MalfunctionJun 25, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT BALLOON HAD INFLATION OR DEFLATION ISSUE DURING THE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19605276 ↗MalfunctionMay 20, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak
ACCORDING TO THE REPORTER, AFTER TWO DAYS OF PATIENT INTUBATION, IT WAS OBSERVED THAT THERE WAS A VOICE LEAK, AND THE ENDOTRACHEAL TUBE'S CUFF PRESSURE WAS INCREASED, BUT THE SYMPTOMS DID NOT IMPROVE, AND WHEN THE CUFF PRESSURE WAS FINALLY INCREASED TO 75 CMH2O, THE CUFF "RUPTURED." THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 19355596 ↗MalfunctionNov 22, 2023Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF WAS NOT INFLATING DUE TO LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18194771 ↗MalfunctionOct 2, 2023Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, AFTER INTUBATION, THE CUFF PRESSURE WAS MEASURED BUT THE ENDOTRACHEAL TUBE'S INFLATION LINE GOT DAMAGED, UNABLE TO CHECK PRESSURE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.
Patient problems: Unintended Extubation
MAUDE report 17857291 ↗MalfunctionMar 27, 2023Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE'S TUBE TIP WAS FOUND DEFORMED OR CRUSHED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16622247 ↗MalfunctionMar 24, 2023Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE DEVICE'S CUFF RUPTURED DURING PROCEDURE. THERE WAS NO PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 16610954 ↗MalfunctionFeb 23, 2023Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE WAS BENT AND THE SUCTION CATHETER COULD NOT BE INSERTED. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 16428991 ↗MalfunctionNov 7, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE CUFF WAS TESTED PRIOR TO USE AND SUCCESSFULLY INFLATED AND DEFLATED USING A SYRINGE WITH 20 CMH2O PRE SSURE. THE DEVICE WAS USED BY THE PATIENT BUT, WHEN EXTUBATED, THE CUFF WAS FOUND NOT CONTRACTING. THE TUBE REPLACEMENT WAS NO LONGER REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 15745773 ↗MalfunctionOct 5, 2022Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE DEVICE WAS CONNECTED TO AN AUTOMATIC CUFF PRESSURE GAUGE AND USED, BUT AN ALARM OCCURRED. THE WATER SEEMED TO BE COMING OUT WHEN THE CUFF WAS DE-AERATED. THE PHYSICIAN TRIED TO INFLATE THE CUFF, BUT IT WOULD NOT INFLATE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 15546572 ↗MalfunctionAug 5, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE CUFF WAS PRE-TESTED WITH AIR USING A HAND CUFF PRESSURE GAUGE BUT THE CUFF DID NOT INFLATE SMOOTHLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15177611 ↗MalfunctionJul 25, 2022Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED AFTER CHECKING THE CUFF, BUT IT WAS FOUND THAT A LEAK OCCURRED AFTER THE INTUBATION. DEALT WITH ANOTHER TUBE. THERE WAS NO PATIENT HARM.
Patient problems: Unintended Extubation
MAUDE report 15097681 ↗MalfunctionJun 1, 2022Crack; Disconnection; Crack; Disconnection
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CONNECTOR DISCONNECTED WHEN THE PRODUCT WAS OPENED. THERE WAS A CRACK ON THE TUBE OF THE SLIP JOINT PART. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14568983 ↗MalfunctionMay 25, 2022Defective Device; Defective Device
ACCORDING TO THE REPORTER, NORMALLY, THE STYLET SHOULD HAVE BEEN INSERTED FROM THE 15 MM CONNECTOR SIDE, BUT IT WAS FOUND TO BE INSERTED FROM THE TUBE TIP SIDE. THERE WAS NO PROBLEM WITH THE TUBE ITSELF, SO IT WAS USED. THEY CHECKED THE IN-HOSPITAL INVENTORY TO SEE WHETHER OR NOT THERE WAS A SIMILAR ONE, BUT THERE WAS NO SIMILAR ONE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14498673 ↗MalfunctionMay 4, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14273244 ↗MalfunctionFeb 28, 2022Disconnection; Disconnection
ACCORDING TO THE REPORTER, DURING USE, THE 15MM CONNECTOR PIECE DETACHED FROM THE TUBE WHILE THE PATIENT WAS INTUBATED. THE PATIENT WAS REINTUBATED.
Patient problems: Unintended Extubation
MAUDE report 13620593 ↗MalfunctionFeb 9, 2022Disconnection; Insufficient Device Problem Information; Disconnection; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING USE, THE 15MM CONNECTOR PIECE DETACHED FROM THE TUBE WHILE THE PATIENT WAS INTUBATED. THE PATIENT WAS REINTUBATED.
Patient problems: Unintended Extubation
MAUDE report 13502405 ↗MalfunctionDec 14, 2021Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING TESTING, THE CUFF OF THE DEVICE DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13006703 ↗MalfunctionOct 22, 2021Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, AFTER INTUBATION, THE CUFF OF THE DEVICE HAD AN AIR LEAKAGE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12682887 ↗MalfunctionSep 15, 2021Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A KINKED TUBE. THERE WAS NO PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 12475384 ↗MalfunctionJul 1, 2021Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A CUFF INFLATION DEFLATION ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12101977 ↗InjuryNov 23, 2020Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE DEVICE'S CUFF DID NOT INFLATE. THE PATIENT WAS REINTUBATED.
Patient problems: Unintended Extubation
MAUDE report 10886571 ↗
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.