Shiley 125137Recalls & reported problems
Covidien LP · Endobronchial Tube Left with CPAP;Endobronchial Suction Catheter;Endobronchial Tube Accessories · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521620025), received between Aug 2, 2018 and Mar 24, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Human-Device Interface Problem” (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
- Human-Device Interface Problem2
- Component Missing1
- Defective Component1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
- Unintended Extubation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING USE OF THE BRONCO CATHETER, THERE WAS A LEAK/ESCAPE IN THE UPPER TIE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682461 ↗MalfunctionDec 18, 2025Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT THE BRONCO CATHETER TUBE CONNECTOR DID NOT ACHIEVE AN ADEQUATE SEAL, PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23843506 ↗MalfunctionJun 23, 2021Defective Component; Human-Device Interface Problem; Defective Component; Human-Device Interface Problem
ACCORDING TO THE REPORTER, THE DEVICE FIBER OPTIC SCOPE WAS VERY DIFFICULT TO REMOVE FROM THE ENDOBRONCHIAL TUBE. OBSTRUCTION WAS RE PORTED AND UNABLE TO FULLY PLACE THE SCOPE DOWN THE TUBE WITHOUT GETTING STOCK AND TO PULLED IT OUT FORCEFULLY. IT WAS REPORTED THAT THE CUSTOMER NOTED THAT IT WAS THE DIAMETER OF THE TUBE THAT WAS GETTING STUCK, BUT THE DIAMETER OF THE SCOPE SHOULD HAVE FIT THROUGH THE TUBE AFTER LOOKING AT SCOPE CROSS REFERENCE CHART. ANOTHER SCOPE HAD TRIED AND REINTUBATION WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 12051114 ↗MalfunctionAug 2, 2018Component Missing
ACCORDING TO THE REPORTER, THE DEVICE'S TUBING WAS MISSING IN BOX. CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7742268 ↗
Other Attachment, breathing, positive end expiratory pressure devices
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- 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 125139Covidien LP · Attachment, breathing, positive end expiratory pressure1 death6 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.