Shiley 125139Recalls & reported problems
Covidien LP · Endobronchial Suction Catheters with Color Coded Connectors; Endobronchial Tube, Left with CPAP; Endobronchial Tube Accessories,(2) Right Angle Swivel Connectors; Carlens Y Adapter · Class 2
- Adverse event reports
- 6
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521620032), received between Mar 7, 2022 and Mar 9, 2026 — classified as 1 death, 5 malfunctions.
The most frequently reported specific device problem is “Defective Component” (2 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 Component2
- Gas/Air Leak2
- Material Split, Cut or Torn1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- Unintended Extubation2
- Cardiac Arrest1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT PRIOR TO USE OF THE BRONCO CATHETER, THE LUMEN OF THE LEFT TUBE WAS CLOSED, MAKING INTUBATION DIFFICULT. THE TUBE WAS REPLACED TO RESOLVED THE ISSUE AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552578 ↗MalfunctionMar 9, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE DEVICE HAD AN AIR LEAK THROUGH A HOLE DURING THE PROCEDURE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 16512829 ↗MalfunctionFeb 21, 2023Defective Component; Defective Component
ACCORDING TO THE REPORTER, AFTER PLACEMENT, THE END TIP OF THE DEVICE WAS CURLING UP AND NOTED TO BE FLIMSIER. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 16409207 ↗MalfunctionFeb 21, 2023Defective Component; Defective Component
ACCORDING TO THE REPORTER, AFTER PLACEMENT, THE END TIP OF THE DEVICE WAS CURLING UP AND NOTED TO BE FLIMSIER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16408401 ↗MalfunctionJul 14, 2022Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE END BRONCHIAL TUBE OVER THE WEEKEND DID NOT HOLD AIR. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT.
Patient problems: Insufficient Information
MAUDE report 15014289 ↗DeathMar 7, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, AT THE TIME OF PATIENT INTUBATION, THE ANESTHESIOLOGIST REALIZED THAT THE DOUBLE-LUMEN BALLOON TUBE WAS BROKEN, THE PATIENT HAD CARDIORESPIRATORY ARREST AND THEREFORE THE TUBE COULD NOT BE RECYCLED. IT WAS NOTED THAT THE TUBE HAD FLUIDS FROM THE PATIENT AND FLOW FROM THE GASTRIC CONTENTS.
Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 13677890 ↗
Other Attachment, breathing, positive end expiratory pressure devices
- N/A 1002Galemed Corporation · Attachment, Breathing, Positive End Expiratory Pressure1 recall1 report
- N/A 1030Galemed Corporation · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- VentStar Resuscitaire CEU MP00310Drägerwerk AG & Co. KGaA · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- WaterPAP™ WP-7700Sunmed, LLC · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- Pneupac 100/905/340-CHIcu Medical, Inc. · Attachment, breathing, positive end expiratory pressure18 reports
- Shiley 125137Covidien LP · Attachment, breathing, positive end expiratory pressure4 reports
- Pneupac 100/905/340Icu Medical, Inc. · Attachment, breathing, positive end expiratory pressure3 reports
- Curaplex MRIPEEP-ABound Tree Medical, LLC · Attachment, breathing, positive end expiratory pressure1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.