Mallinckrodt 125037Recalls & reported problems
Covidien LP · Endobronchial Suction Catheters with Color Coded Connectors; Endobronchial Tube; Endobronchial Tube Accessories,Left,(2) Right Angle Swivel Connectors; Carlens Y Adapter · Class 2
All models of Mallinckrodt (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Covidien bronchial tube used to keep a patient's airway open during lung surgery and ventilation. The 49 reports mostly describe the tube's inflatable cuff not deflating or leaking air, so air stayed trapped after the tube was removed; a few mention partial blockage and one fiberscope getting stuck inside the tube during surgery, briefly interrupting the operation. Two reports describe injuries and no deaths. There are no recalls naming 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
- 49
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 30884522008741), received between Mar 17, 2017 and Oct 4, 2024 — classified as 2 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (33 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Deflation Problem33
- Inflation Problem7
- Use of Device Problem4
- Partial Blockage3
- Gas/Air Leak2
- Appropriate Device Problem Term/Code Not Available1
- Material Integrity Problem1
Patient problems
- No Patient Involvement41
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient3
- Unintended Extubation2
- Low Oxygen Saturation1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE BRONCO CATHETER'S TRACHEAL CUFF HAD AN AIR LEAK DURING THE PROCEDURE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 20376817 ↗InjuryDec 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, DURING A PROCEDURE TO REMOVE THE PATIENT¿S LEFT LUNG, THE FIBERSCOPE STUCK IN THE LEFT BRONCO CATHETER LUMEN. THE PATIENT WAS EXTUBATED AND REINTUBATED WITH A NORMAL LOW-PRESSURE 7F PROBE, WHICH RESULTED IN A MOMENTARY SUSPENSION OF SURGERY. THE PATIENT DESATURATED DESPITE ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) IN PLACE.
Patient problems: Low Oxygen Saturation; Unintended Extubation
MAUDE report 18329001 ↗MalfunctionFeb 22, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE DEVICE AIR REMAINED AFTER REMOVAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13582541 ↗MalfunctionFeb 22, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE DEVICE AIR REMAINED AFTER REMOVAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13582451 ↗MalfunctionFeb 22, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13582401 ↗MalfunctionJul 13, 2020Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF LEAKAGE WHEN INFLATED. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10265545 ↗MalfunctionOct 14, 2019Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE BALLOON DID INFLATE BUT WOULD NOT DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9186241 ↗MalfunctionApr 3, 2019Partial Blockage; Partial Blockage
ACCORDING TO THE REPORTER, WHEN AIR WAS ATTEMPTED TO BE REMOVED AFTER CUFF CHECK WAS PERFORMED, DEGASSING WAS UNABLE TO BE PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8478866 ↗MalfunctionDec 27, 2018Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD AIR LEAK FROM TRACHEAL CUFF UPON CUFF CHECK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8200068 ↗MalfunctionJul 6, 2018Partial Blockage; Partial Blockage
ACCORDING TO THE REPORTER, PRIOR TO USE, THE AIR FROM THE DEVICE WAS NOT DEFLATED COMPLETELY DURING CUFF TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7666677 ↗InjuryMay 21, 2018Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, THE DEVICE'S CUFF COULD NOT BE INFLATED. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7530289 ↗MalfunctionApr 4, 2018Partial Blockage; Partial Blockage
ACCORDING TO THE REPORTER, DURING CUFF TEST, IT WAS FOUND THAT THE TRACHEAL CUFF HAD A LEAK. IT WAS INDICATED THERE WAS NO PATIENT I INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7397919 ↗MalfunctionMar 2, 2018Deflation Problem; Deflation Problem
ACCORDING TO THE REPORTER, DURING TESTING, THE INFLATED TRACHEAL CUFF DID NOT DEFLATE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7309423 ↗MalfunctionMar 2, 2018Deflation Problem; Deflation Problem
ACCORDING TO THE REPORTER, DURING TESTING, THE INFLATED TRACHEAL CUFF DID NOT DEFLATE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7309414 ↗MalfunctionNov 30, 2017Deflation Problem; Deflation Problem
MEDTRONIC RECEIVED A COMMUNICATION REGARDING A CUFF THAT WOULDN'T DEFLATE. ACCORDING TO THE REPORTER, DURING THE TEST, TUBE DID NOT DEFLATE AFTER BEING INFLATED. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7071757 ↗MalfunctionNov 20, 2017Deflation Problem; Deflation Problem
MEDTRONIC RECEIVED A COMMUNICATION REGARDING A CUSTOMER THAT COULD TAKE OUT THE AIR FROM THE BALLOON. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7046982 ↗MalfunctionNov 20, 2017Deflation Problem; Deflation Problem
MEDTRONIC RECEIVED A COMMUNICATION REGARDING A CUSTOMER THAT COULD TAKE OUT THE AIR FROM THE BALLOON. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7046971 ↗MalfunctionNov 16, 2017Deflation Problem; Deflation Problem
MEDTRONIC RECEIVED A COMMUNICATION REGARDING A CUFF THAT COULD NOT BE DEFLATED. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILE CHECKING PRIOR TO USE.
Patient problems: No Patient Involvement
MAUDE report 7039334 ↗MalfunctionNov 14, 2017Deflation Problem; Deflation Problem
MEDTRONIC RECEIVED A COMMUNICATION REGARDING DIFFICULTY DEFLATING THE CUFF. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7029624 ↗MalfunctionNov 14, 2017Deflation Problem; Deflation Problem
MEDTRONIC RECEIVED A COMMUNICATION REGARDING DIFFICULTY DEFLATING THE CUFF. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7029618 ↗MalfunctionNov 14, 2017Deflation Problem; Deflation Problem
MEDTRONIC RECEIVED A COMMUNICATION REGARDING DIFFICULTY DEFLATING THE CUFF. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7029601 ↗MalfunctionNov 7, 2017Inflation Problem; Inflation Problem
MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, THE CUFF DID NOT INFLATE SYMMETRICALLY. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7006450 ↗MalfunctionNov 6, 2017Deflation Problem; Deflation Problem
MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, THE AIRWAY CUFF DID NOT DEFLATE. IT WAS REPORTED THAT PART OF THE POLYURETHANE CUFF WAS COVERING THE DEFLATION HOLE OF THE CUFF. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7003532 ↗MalfunctionOct 4, 2017Deflation Problem; Deflation Problem
MEDTRONIC RECEIVED A REPORT THAT DURING THE PRE-TEST THE CUFF WOULD NOT DEFLATE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6914505 ↗MalfunctionOct 4, 2017Deflation Problem; Deflation Problem
MEDTRONIC RECEIVED A REPORT THAT DURING THE PRE-TEST THE TUBE'S CUFF WOULD NOT DEFLATE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6914409 ↗
Other TUBE, BRONCHIAL (W/WO CONNECTOR) devices
- Shiley 125037Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)1 death209 reports
- Shiley 125035Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)114 reports
- Shiley 126035Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)50 reports
- Mallinckrodt 126037Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)47 reports
- Shiley 125039Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)40 reports
- Shiley 126039Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)39 reports
- Mallinckrodt 125035Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)34 reports
- Shiley 125032Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)34 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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