Shiley 86233 (UDI 10884521797253)Recalls & reported problems
Covidien LP · Oral/Nasal Tracheal Tube Cuffless Non DEHP, Murphy Eye · Class 2
Quick summary
This Shiley cuffless oral/nasal tracheal tube is used to keep an airway open during surgery or ventilation. The 43 reports mostly describe the tube coming apart or failing before or during use — connectors and pilot lines breaking or cracking and leaking air, the tube splitting or being cut, flow becoming obstructed, and pieces or damage found on inspection, sometimes causing the tube to come out unexpectedly. Two injuries and no deaths were reported, and 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
- 42
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10884521797253), received between Sep 2, 2019 and Jul 13, 2026 — classified as 2 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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
- Disconnection14
- Obstruction of Flow8
- Defective Component5
- Material Split, Cut or Torn5
- Contamination /Decontamination Problem4
- Appropriate Device Problem Term/Code Not Available1
- Component Missing1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Patient Involvement6
- Unintended Extubation6
- Insufficient Information2
- Unspecified Tissue Injury2
- Cardiac Arrest1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25804235 ↗MalfunctionJun 26, 2026Disconnection
IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CONNECTION TIP HAD ISSUES AND DISCONNECTING FROM THE TUBE, MAKING IT IMPOSSIBLE TO USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637989 ↗MalfunctionMar 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING ROUTINE INSPECTION OF SUPPLIES, DAMAGE TO THE INTEGRITY OF AN ENDOTRACHEAL TUBE WAS FOUND. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24622269 ↗MalfunctionNov 4, 2025Disconnection; Disconnection
IT WAS REPORTED THAT UPON TAKING OUT THE ENDOTRACHEAL TUBE IN PREPARATION FOR THE OPERATION, THE CONNECTOR WAS FOUND TO BE LOOSE. THE CONNECTOR WAS IMMEDIATELY TIGHTENED, AND A THOROUGH INSPECTION CONFIRMED THAT THERE WAS NO LOOSENESS. THE INTUBATION PROCEDURE WAS THEN PERFORMED, WITH NO ADVERSE EFFECTS ON THE INFANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468852 ↗MalfunctionSep 17, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE NUMBERS THAT MARK PLACEMENT WORN PREMATURELY WHICH MADE THEM ILLEGIBLE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 23076644 ↗MalfunctionSep 8, 2025Crack; Crack
IT WAS REPORTED THAT DURING USE, THERE WAS A CRACK FOUND IN 3.0 MM CONNECTOR OF THE ENDOTRACHEAL TUBE AND CAUSED AN AIR LEAKED, AS SHOWN IN THE IMAGE ATTACHED. THE TOP OF THE TUBE WAS TAKEN OFF AND REPLACED WITH ONE FROM ANOTHER TUBE. A NEW TUBE WASN'T REINSERTED. THERE WAS NO PATIENT INJURY,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991582 ↗MalfunctionJul 16, 2025Defective Component; Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn
IT WAS REPORTED THAT A ENDOTRACHEAL TUBE IN AN UNOPENED PACKAGE WAS FOUND TO BE CUT AND SHARP PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22527365 ↗MalfunctionJul 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE WAS FOUND TO BE CUT IN HALF UPON RECEIPT AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22375353 ↗MalfunctionJun 30, 2025Defective Component; Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn
IT WAS REPORTED THAT A ENDOTRACHEAL TUBE IN AN UNOPENED PACKAGE WAS FOUND TO BE CUT AND SHARP DURING PRE-OPERATIVE PREPARATION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22367626 ↗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. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 22181860 ↗MalfunctionJun 4, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WERE FOUR ENDOTRACHEAL TUBES THAT HAD DISCONNECTION FROM THE CONNECTOR AS SHOWN IN THE ATTACHED PHOTO INSIDE THE PACKAGING PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22145560 ↗MalfunctionJun 4, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WERE FOUR ENDOTRACHEAL TUBES THAT HAD DISCONNECTION FROM THE CONNECTOR AS SHOWN IN THE ATTACHED PHOTO INSIDE THE PACKAGING PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22145548 ↗MalfunctionJun 4, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WERE FOUR ENDOTRACHEAL TUBES THAT HAD DISCONNECTION FROM THE CONNECTOR AS SHOWN IN THE ATTACHED PHOTO INSIDE THE PACKAGING PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22145478 ↗MalfunctionJun 4, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WERE FOUR ENDOTRACHEAL TUBES THAT HAD DISCONNECTION FROM THE CONNECTOR AS SHOWN IN THE ATTACHED PHOTO INSIDE THE PACKAGING PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22145333 ↗MalfunctionMay 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING INSPECTION, THE ENDOTRACHEAL TUBE HAVE COME APART. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22051984 ↗MalfunctionDec 9, 2024Mechanical Problem; Mechanical Problem
ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE'S END KEPT POPPING OFF AND THE TUBE'S END STRETCHED OUT LEADING TO PATIENT NEEDING TO BE REINTUBATED.
Patient problems: Unintended Extubation
MAUDE report 20878528 ↗MalfunctionNov 15, 2024Disconnection; Disconnection
ACCORDING TO THE REPORTER, PRIOR TO USE, THE TWO ENDOTRACHEAL TUBE'S CONNECTOR AND THE TUBE BODY SEPARATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20692390 ↗MalfunctionNov 14, 2024Disconnection; Disconnection
ACCORDING TO THE REPORTER, PRIOR TO USE, THE TWO ENDOTRACHEAL TUBE'S CONNECTOR AND THE TUBE BODY SEPARATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20692347 ↗MalfunctionNov 6, 2024Disconnection; Disconnection
ACCORDING TO THE REPORTER, DURING INSPECTION, FOUR ENDOTRACHEAL TUBE'S 15MM CONNECTORS WERE DISCONNECTED FROM THE TUBE INSIDE THE INDIVIDUAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620736 ↗MalfunctionNov 6, 2024Disconnection; Disconnection
ACCORDING TO THE REPORTER, DURING INSPECTION, FOUR ENDOTRACHEAL TUBE'S 15MM CONNECTORS WERE DISCONNECTED FROM THE TUBE INSIDE THE INDIVIDUAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620155 ↗MalfunctionNov 6, 2024Disconnection; Disconnection
ACCORDING TO THE REPORTER, DURING INSPECTION, FOUR ENDOTRACHEAL TUBE'S 15MM CONNECTORS WERE DISCONNECTED FROM THE TUBE INSIDE THE INDIVIDUAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620099 ↗MalfunctionNov 6, 2024Disconnection; Disconnection
ACCORDING TO THE REPORTER, DURING INSPECTION, FOUR ENDOTRACHEAL TUBE'S 15MM CONNECTORS WERE DISCONNECTED FROM THE TUBE INSIDE THE INDIVIDUAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20619922 ↗MalfunctionOct 30, 2024Disconnection; Disconnection
ACCORDING TO THE REPORTER, DURING USE, THE CAP OF THE ENDOTRACHEAL TUBE KEPT POPPING OFF WHEN ON A PATIENT. THE TUBE WAS REPLACED AND WORKED.
Patient problems: Unintended Extubation
MAUDE report 20571554 ↗MalfunctionJul 22, 2024Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE REPORTER, THE SUCTION WAS STUCK INSIDE THE ENDOTRACHEAL TUBE DURING THE PROCEDURE. THE PROBLEM REMAINED AS HEALTH CARE STAFF WAS UNABLE TO PROVIDE SUCTION CARE FOR THE PATIENT, BUT THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19791014 ↗MalfunctionJul 22, 2024Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE REPORTER, THE SUCTION WAS STUCK INSIDE THE ENDOTRACHEAL TUBE DURING THE PROCEDURE. THE PROBLEM REMAINED AS HEALTH CARE STAFF WAS UNABLE TO PROVIDE SUCTION CARE FOR THE PATIENT, BUT THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19790708 ↗
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.