Mallinckrodt 18775Recalls & reported problems
Covidien LP · TaperGuard Oral/Nasal Tracheal Tube Murphy Eye · Class 2
All models of Mallinckrodt (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Covidien TaperGuard oral/nasal tracheal tube, a breathing tube used to intubate patients. The 32 reports mostly describe cuff problems — the cuff would not inflate, held a hole, or lost pressure, sometimes forcing the patient to be reintubated — plus some contamination and fading size markings. Reports mention 11 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
- 32
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 50884522007601), received between Apr 27, 2017 and Mar 24, 2025 — classified as 11 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (13 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Inflation Problem13
- Contamination5
- Use of Device Problem5
- Gas/Air Leak4
- Air Leak3
- Labelling, Instructions for Use or Training Problem3
- Connection Problem1
- Defective Component1
Patient problems
- No Patient Involvement12
- No Information7
- Extubate6
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions1
- Unintended Extubation1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING THE USE OF AN ENDOTRACHEAL TUBE, A PATIENT WAS INTUBATED AFTER A CODE. THE ENDOTRACHEAL TUBE'S CUFF WAS SUCCESSFULLY INFLATED PRIOR TO INSERTION, BUT AFTER PLACEMENT, THE CUFF WOULD NOT INFLATE, REQUIRING AN EXCHANGE. RE-CANNULATION OFA REPLACEMENT TUBE WAS NECESSARY. THERE WAS A REPORT OF OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS AS PATIENT HARM.
Patient problems: Unintended Extubation; Unspecified Tissue Injury
MAUDE report 21677830 ↗InjurySep 15, 2020Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, AFTER OPENING A NEW PRODUCT AND INTUBATING THE PATIENT, A CUFF LEAK WAS FOUND. THE PATIENT WAS REINTUBATED.
Patient problems: Extubate
MAUDE report 10537669 ↗MalfunctionJul 6, 2020Use of Device Problem; Defective Component; Use of Device Problem; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT INFLATE BECAUSE THERE WAS A HOLE IN THE CUFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10235597 ↗MalfunctionJan 9, 2020Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, THE UNIT WAS FOUND TO BE UNCLEAR AND FUZZY. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9571917 ↗MalfunctionJan 8, 2020Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, THE TUBE SIZE MARKINGS OF THE DEVICE WAS FADING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9566096 ↗MalfunctionJan 8, 2020Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, THE TUBE SIZE MARKINGS OF THE DEVICE WAS FADING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9566077 ↗InjuryAug 13, 2019Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE TUBES HAD CUFF INFLATION/DEFLATION ISSUE. REINTUBATION WAS REQUIRED.
Patient problems: Extubate; No Information
MAUDE report 8891123 ↗InjuryAug 5, 2019Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE PILOT VALVE OF THE ELEVEN TUBES DEFLATED IN A SHORT PERIOD. IT WAS REPORTED THAT THE TUBE LOST PRESSURE AFTER 2 TO 3 DAYS IN AVERAGE AND WAS TESTED WITH CUFOMETER WITH PRESSURE NOT STABLE. AFTER TAKING OUT OF THE PATIENT, THE TUBE WAS TESTED AND THERE WAS NO LEAKAGE IN THE CUFF. REINTUBATION WAS REQUIRED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION.
Patient problems: No Information
MAUDE report 8858760 ↗MalfunctionJul 18, 2019Disconnection; Disconnection
ACCORDING TO THE REPORTER, AFTER CANNULATION, THE SLIP JOINT CAME OFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8803699 ↗InjuryJun 18, 2019Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, THE DEVICE HAD AN AIR LEAK. THERE WAS CUFFED INFLATION AND DEFLATION ISSUE. THE PATIENT WAS RE-INTUBATED.
Patient problems: Extubate
MAUDE report 8710375 ↗InjuryMay 3, 2019Inflation Problem; Use of Device Problem; Gas/Air Leak; Inflation Problem; Use of Device Problem; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE UNIT HAD LEAKAGE. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.
Patient problems: No Information
MAUDE report 8579225 ↗InjuryApr 17, 2019Inflation Problem; Use of Device Problem; Gas/Air Leak; Inflation Problem; Use of Device Problem; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE UNIT HAD LEAKAGE. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.
Patient problems: Extubate
MAUDE report 8524391 ↗InjuryApr 10, 2019Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE UNIT HAD LEAKAGE. THE CUSTOMER INDICATED THAT THE PATIENT HAD A RE-INTUBATION.
Patient problems: Extubate; No Information
MAUDE report 8501744 ↗InjuryMar 5, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE REPORTER, THE TIP DID NOT FIT THE TUBE AND WITHOUT ANYONE TOUCHING IT, THERE WAS DESATURATION BECAUSE OF DISCONNECTION FROM THE RESPIRATORY MACHINE THAT CAUSED HYPOXIA. THE TIP WAS CHANGED FROM 7.5 TO 7. THE PATIENT WAS RE-INTUBATED.
Patient problems: Extubate
MAUDE report 8389744 ↗MalfunctionDec 26, 2018Leak/Splash; Leak/Splash
ACCORDING TO THE REPORTER, THE UNIT HAD CUFF INFLATION/DEFLATION ISSUE. THEY USED A SYRINGE TO PUSH AIR IN AND OUT OF THE CUFF. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8196601 ↗MalfunctionSep 26, 2018Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7910694 ↗MalfunctionAug 8, 2018Inflation Problem
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. IT WAS REPORTED THAT AN AIR WAS PUT INTO THE CUFF TO INFLATE BUT IT DID NOT INFLATE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7763805 ↗MalfunctionMar 1, 2018Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, DURING CUFF TEST, THE INFLATED CUFF LEAKED AIR. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7306021 ↗MalfunctionMar 1, 2018Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, DURING CUFF TEST, THE INFLATED CUFF LEAKED AIR. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7305971 ↗MalfunctionDec 7, 2017Inflation Problem; Inflation Problem
MEDTRONIC RECEIVED A REPORT THAT THE CUFF COULD NOT BE INFLATED. THE CUSTOMER REPORTED THE PATIENT STATUS WAS UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7097881 ↗MalfunctionDec 7, 2017Inflation Problem; Inflation Problem
ACCORDING TO REPRESENTATIVE, DURING THE CUFF TEST, IT WAS FOUND THAT THE CUFF LEAKED AIR. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7097761 ↗InjuryOct 9, 2017Air Leak; Inflation Problem; Air Leak; Inflation Problem
MEDTRONIC RECEIVED A REPORT THE TRACHEOSTOMY TUBE EXPERIENCE INFLATION/DEFLATION ISSUES. CUSTOMER INDICATED THERE WAS NO PATIENT INJ URY WITH THIS EVENT.
Patient problems: No Information
MAUDE report 6932083 ↗MalfunctionSep 28, 2017Inflation Problem; Inflation Problem
MEDTRONIC RECEIVED A COMMUNICATION THAT INTUBATION WAS PROCEEDED IN ER THEN THE PATIENT WAS MOVED TO MICU WITH THE TUBE. IN THE MICU, THE AIR DID NOT GET INTO INSIDE. IT WAS FOUND THE CUFF WAS TORN. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6902845 ↗MalfunctionAug 23, 2017Contamination; Contamination
MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE BEFORE EVEN OPENING IT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6812631 ↗MalfunctionJul 31, 2017Contamination; Contamination
MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6756203 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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