Shiley 86233 (UDI 10884521620247)Recalls & reported problems
Covidien LP · Oral/Nasal Tracheal Tube Cuffless Non DEHP, Murphy Eye · Class 2
Quick summary
This Shiley oral/nasal tracheal tube is a cuffless breathing tube used to keep the airway open. The 45 reports mostly describe tubes that are too rigid or slack, connectors coming loose, and depth markings wearing off, plus some contamination and labelling complaints. Five injuries are described, including a pressure sore in a baby's nostril and a cracked tube tip; no deaths. There are no recalls for 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
- 45
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10884521620247), received between Oct 16, 2018 and Jul 30, 2025 — classified as 5 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Defective Component” (17 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
- Defective Component17
- Material Deformation7
- Contamination /Decontamination Problem5
- Device Markings/Labelling Problem3
- Labelling, Instructions for Use or Training Problem3
- Loose or Intermittent Connection2
- Obstruction of Flow2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Patient Involvement28
- Unintended Extubation5
- Extubate4
- Insufficient Information3
- No Consequences Or Impact To Patient3
- No Information2
- Edema1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE TUBE WAS RIGID AND CAUSED A PRESSURE ULCER FOUND ON THE LEFT NOSTRIL OF THE BABY AND THE SKIN WAS PURPLE. THE TUBE WAS EXTUBATED BUT IT WAS UNKNOWN IF THERE WAS A REPLACEMENT.
Patient problems: Pressure Sore/Ulcer
MAUDE report 22662050 ↗MalfunctionJun 11, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE TUBE WAS TOO SLACK IN THE AREA OF THE HOLE OR MURPHY EYE AND THEREFORE BENDS AND OBSTRUCTS THE FEEDING. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information; Unintended Extubation
MAUDE report 22185014 ↗MalfunctionMar 19, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE CIRCUIT TUBE CONNECTOR DISCONNECTED FROM THE ENDOTRACHEAL TUBE. THE TUBE CONNECTOR WAS DESCRIBED AS LOOSE AND NOT FIRMLY SECURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21646243 ↗MalfunctionFeb 28, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, THE NUMBERS OR MARKING HAD WORN OFF, EVEN ABOVE WHERE THE ENDOTRACHEAL TUBE WAS TAPED DURING USE. THE TUBE WAS REMOVED ELECTIVELY AND THERE WAS NO PATIENT HARM.
Patient problems: Unintended Extubation
MAUDE report 18798983 ↗MalfunctionFeb 28, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, THE NUMBERS OR MARKING HAD WORN OFF, EVEN ABOVE WHERE THE ENDOTRACHEAL TUBE WAS TAPED DURING USE AND CAUSED UNPLANNED SELF-EXTUBATION.
Patient problems: Unintended Extubation
MAUDE report 18798777 ↗MalfunctionDec 20, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S MARKINGS WORE OFF DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18363242 ↗MalfunctionApr 13, 2021Connection Problem; Connection Problem
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE 15MM CONNECTOR OF THE DEVICE WAS TOO LOOSE AND EASILY FELL OFF FROM THE VENTILATOR. THE PATIENT WAS REINTUBATED. THERE WAS NO PATIENT INJURY.
Patient problems: Unintended Extubation
MAUDE report 11656881 ↗InjuryJul 23, 2020Crack; Crack
ACCORDING TO THE REPORTER, THE TUBE TIP GOT CRACKED AFTER A WHILE AFTER USE. THE PATIENT WAS REINTUBATED.
Patient problems: Extubate; Unintended Extubation
MAUDE report 10314701 ↗MalfunctionMar 20, 2020Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S PHYSICAL DAMAGE CAUSED GLOTTIS EDEMA.
Patient problems: Edema
MAUDE report 9859570 ↗MalfunctionFeb 14, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, DURING USED, THE DEVICE CUFF DEHP MATERIAL CAUSED GLOTTIS SWELLING.
Patient problems: Swelling
MAUDE report 9711933 ↗MalfunctionFeb 11, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE REPORTER, THE UNIT TUBE WAS STERILE PACKED, WHEN THE TUBE WAS UNPACKED THERE WAS ADHESIVE RESIDUE ON THE TUBE. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9693196 ↗InjuryNov 20, 2019Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE REPORTER, A TUBE WAS PLACED IN A NEWBORN FOR INTUBATION AND PATIENT'S CO2 INCREASED. THE NURSE COULD NOT PASS A CATHETER THROUGH THE TUBE TO CLEAR THE AIRWAY. THE TUBE WAS PULLED FROM THE PATIENT AND A NEW ONE WAS PLACED. WHEN IT WAS PULLED, THEY NOTICED THAT THE END OF THE TUBE THAT WAS INSERTED TO THE PATIENT APPEARED TO HAVE ADDITIONAL NOTCH OF PLASTIC ON THE INSIDE OF THE TUBE.
Patient problems: Extubate
MAUDE report 9349984 ↗MalfunctionOct 9, 2019Missing Information; Missing Information
ACCORDING TO THE REPORTER, THE DEVICE WAS DIFFICULT TO INTUBATE TO THE CORRECT GRADUATION DESIRED BECAUSE SOME GRADUATIONS WERE MISSING WITH THE NEW PACKAGING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9173643 ↗MalfunctionSep 13, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE REPORTER, THE UNIT HAD STICKY RESIDUE END OF TUBE. CLOUDY, ROUGH SURFACE THROUGHOUT. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9040414 ↗MalfunctionSep 13, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE REPORTER, THE UNIT HAD STICKY RESIDUE END OF TUBE. CLOUDY, ROUGH SURFACE THROUGHOUT. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9040315 ↗MalfunctionSep 2, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953469 ↗MalfunctionSep 2, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953407 ↗MalfunctionSep 2, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953406 ↗MalfunctionSep 2, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953405 ↗MalfunctionSep 2, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953404 ↗MalfunctionSep 2, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953358 ↗MalfunctionSep 2, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE A STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953279 ↗MalfunctionSep 2, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE A STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953275 ↗MalfunctionSep 2, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE A STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953273 ↗MalfunctionSep 2, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE A STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953271 ↗
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.