Shiley 87465Recalls & reported problems
Covidien LP · Oral/Nasal Endotracheal Tube, Intermediate Cuff Non DEHP · Class 2
Quick summary
This Shiley 87465 oral/nasal endotracheal tube is used to keep a patient's airway open during surgery or ventilation. The 29 reports mostly describe cuff problems — the inflatable seal bursting or leaking during placement, sometimes triggering ventilator alarms and requiring the patient to be reintubated — plus connector and material issues. No deaths or injuries are reported. No recalls name this device. Reports rose from 2 in the prior 12 months to 7 in the most recent 12 months.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10884521815254), received between Aug 20, 2024 and Mar 24, 2026 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Defective Component” (20 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 Component20
- Use of Device Problem6
- Connection Problem1
- Contamination /Decontamination Problem1
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information3
- Unintended Extubation1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2026Gas/Air Leak
IT WAS REPORTED THAT AFTER INTUBATION AND INFLATION OF THE ENDOTRACHEAL TUBE'S CUFF, THE PATIENT WAS PLACED ON MECHANICAL VENTILATION. FOLLOWING TWO VENTILATION CYCLES, A NOISE WAS HEARD AND THE VENTILATOR¿S LOW-PRESSURE/LEAK ALARM WAS TRIGGERED. THE CARE TEAM IDENTIFIED A LEAK AND PERFORATION IN THE CUFF, NECESSITATING REINTUBATION OF THE PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME AFTER THE TUBE REPLACEMENT.
Patient problems: Unintended Extubation
MAUDE report 24676867 ↗MalfunctionMar 23, 2026Connection Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE EXPERIENCED ISSUES WITH THE 15MM CONNECTOR AS IT DISCONNECTS EASILY AND THERE WAS DIFFICULTY FULLY INSERTING IT PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24669659 ↗MalfunctionFeb 3, 2026Use of Device Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT PRIOR TO USE, IT WAS FOUND THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS DIRTY. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE CUFF WAS BURST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248766 ↗MalfunctionNov 20, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF BURST DURING INTUBATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23606369 ↗MalfunctionNov 11, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF "BURST" DURING INTUBATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23526085 ↗MalfunctionNov 11, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF "BURST" DURING INTUBATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23526057 ↗MalfunctionJul 30, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THERE WAS AN INFLATION ISSUE AND A DELAY IN PILOT BALLOON DEFLATION DURING EQUIPMENT CHECK IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22668883 ↗MalfunctionJul 23, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE ENDOTRACHEAL TUBE'S PILOT BALLOON INFLATION AND A DELAY IN THE PILOT BALLOON'S DEFLATION DURING THE EQUIPMENT CHECK. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580009 ↗MalfunctionAug 22, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20028665 ↗MalfunctionAug 22, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20027590 ↗MalfunctionAug 22, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20025650 ↗MalfunctionAug 22, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20025552 ↗MalfunctionAug 21, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20018182 ↗MalfunctionAug 21, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20018086 ↗MalfunctionAug 21, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20016941 ↗MalfunctionAug 21, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20015583 ↗MalfunctionAug 21, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20015304 ↗MalfunctionAug 21, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20012292 ↗MalfunctionAug 21, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20011947 ↗MalfunctionAug 21, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20011373 ↗MalfunctionAug 20, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20007380 ↗MalfunctionAug 20, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20005893 ↗MalfunctionAug 20, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20005746 ↗MalfunctionAug 20, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20003124 ↗MalfunctionAug 20, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS OF THE TWENTY ENDOTRACHEAL TUBES WERE LARGER THAN THE ANNOUNCED SIZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20003109 ↗
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.