Shiley 86235 (UDI 10884521619913)Recalls & reported problems
Covidien LP · Oral/Nasal Tracheal Tube Cuffless Non DEHP, Murphy Eye · Class 2
Quick summary
This Shiley 86235 is a cuffless tracheal (breathing) tube used to secure a patient's airway during surgery or ventilation. The 33 adverse event reports mostly describe markings or dye wearing off so the tube's depth at the lip could no longer be read, along with damaged components, contamination, and connector issues. Reports include 4 injuries and no deaths, with symptoms such as wheezing, distress, and difficulty breathing. 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
- 33
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884521619913), received between Aug 19, 2019 and Aug 9, 2024 — classified as 4 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component13
- Contamination /Decontamination Problem7
- Labelling, Instructions for Use or Training Problem5
- Connection Problem3
- Insufficient Device Problem Information3
- Disconnection2
- Use of Device Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Patient Involvement21
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information3
- Extubate2
- No Consequences Or Impact To Patient2
- Discomfort1
- Distress1
- Low Oxygen Saturation1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2024Labelling, Instructions for Use or Training Problem; Insufficient Device Problem Information; Labelling, Instructions for Use or Training Problem; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING USE, THE MARKING OF THE ENDOTRACHEAL TUBE ON THE LIP WAS WORN OFF AND UNABLE TO BE READ. BASED ON THE REPORT, THE PATIENT WAS EXTUBATED AND NO INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 19951646 ↗MalfunctionDec 18, 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 18349000 ↗MalfunctionDec 4, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S MARKINGS WEAR OFF BEFORE USE. THE HOSPITAL HAD BEEN USING 3M MULTIPORE TAPE FOR SECUREMENT FOR OVER 10 YEARS AND HAD NO ISSUE UNTIL RECENTLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18261423 ↗MalfunctionJan 6, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE ENDOTRACHEAL TUBE HAD AN ISSUE WITH DYE WEARING OFF. THERE WERE NO CLEANING PRODUCTS NOTED, AND THE APPLICATION OF THE TAPE WAS AWAY FROM THE AREA THAT WAS WEARING OFF ON THE TUBE. THERE WAS NO WAY TO KNOW IF THE TUBE WAS PROPERLY PLACED, AND NEEDED X-RAYS TO CONFIRM. ALSO, SUCTION WAS IMPAIRED. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16111757 ↗MalfunctionMay 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE END TIP OF THE CANNULA HAD HOLES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14339477 ↗InjurySep 28, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, THE DEVICE HAD UNKNOWN ISSUE, PATIENT SHOWED SIGN OF DISTRESS AND STRIDOR WITH DIFFICULTY OF BREATHING.
Patient problems: Discomfort; Distress; Wheezing
MAUDE report 12540283 ↗InjuryMay 5, 2021Component Missing; Connection Problem; Component Missing; Connection Problem
ACCORDING TO THE REPORTER, THE DEVICE'S PACKAGING CLEARLY STATED THAT IT WAS A 3.5 ETT TUBE. WHEN REMOVING THE SCOPE IT GOT STUCK ON THE DEVICE'S END CONNECTOR. THE BRONCHOSCOPE WAS TORN DOWN TO THE FIBEROPTIC THREADS. IT WAS NOTED THAT THE 3.5 ETT CONNECTOR WAS ACTUALLY A SIZE 3.0. THE PATIENT DESATURATED DURING THE PROCEDURE. BUT ONCE THE SCOPE WAS OUT, THE PATIENT'S VITALS STABILIZED.
Patient problems: Low Oxygen Saturation
MAUDE report 11778301 ↗MalfunctionMar 31, 2021Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE REPORTER, THE DEVICE'S SPUTUM SUCTION TUBE SIZE 6 WAS INSERTED TO SUCK PATIENT'S SPUTUM, BUT IT WAS HARD TO MOVE OUT. THE PATIENT WAS RE-INTUBATED WITH NEW ENDOTRACHEAL TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 11595019 ↗MalfunctionApr 21, 2020Disconnection; Connection Problem; Insufficient Device Problem Information; Disconnection; Connection Problem; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING USE, THE CUFFLESS 2.5MM, 3.0MM AND 3.5MM TRACHEAL TUBES COULD NOT BE CONNECTED TO THE MANUAL RESUSCITATION BAG FOR PROPER VENTILATION. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9980263 ↗MalfunctionApr 21, 2020Disconnection; Connection Problem; Insufficient Device Problem Information; Disconnection; Connection Problem; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING USE, THE CUFFLESS 2.5MM, 3.0MM AND 3.5MM TRACHEAL TUBES COULD NOT BE CONNECTED TO THE MANUAL RESUSCITATION BAG FOR PROPER VENTILATION. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9980257 ↗InjuryMar 20, 2020Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE DEVICE HAD A PHYSICAL DAMAGE. THE PATIENT HAD "EDEMA OF GLOTI CASUATED BY THE ENDOTRACHEAL TUBE." MEDICATIONS WERE USED TO TREAT THE EDEMA. RE-CANNULATION HAS BEEN REQUIRED.
Patient problems: Extubate
MAUDE report 9863202 ↗InjuryMar 18, 2020Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE DEVICE HAD A PHYSICAL DAMAGE. THE PATIENT HAD "EDEMA OF GLOTI CAPSULATED BY THE ENDOTRACHEAL TUBE." MEDICATIONS WERE USED TO TREAT THE EDEMA. RE-CANNULATION HAS BEEN REQUIRED.
Patient problems: Extubate
MAUDE report 9850179 ↗MalfunctionDec 6, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, THE UNIT GRADATIONS WAS INCONSISTENTLY PLACED ALONG THE TUBE. IT WAS INCORRECT AND INADEQUATE FOR GAUGING THE DEPTH OF THE TUBE. THEY COULD NOT TELL WHICH TUBES HAVE THE CORRECT DEPTH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9433616 ↗MalfunctionNov 27, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE WAS STICKY AND ROUGH. THE CUSTOMER INDICATED NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9387686 ↗MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970054 ↗MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8969992 ↗MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8969976 ↗MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8969956 ↗MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8969937 ↗MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8968232 ↗MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8968214 ↗MalfunctionSep 5, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8968126 ↗MalfunctionSep 5, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8968124 ↗MalfunctionSep 5, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8968122 ↗MalfunctionSep 2, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, FIVE DEVICES HAD STICKY OR CLOUDY RESIDUE ON THE TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8953453 ↗
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.