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Chartis Catheter G3Recalls & reported problems

Pulmonx Corporation · The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811907030928), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Flow” (1 report).

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.

Most reported problems

Device problems

  • No Flow1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 24, 2022No Flow

    CHARTIS CATHETER WOULD NOT WORK PROPERLY AND WAS NOT SHOWING ANY FLOW ON THE CHARITS MACHINE. CHANGED TO A NEW CATHETER AND IT WORKED FINE. I ATTEMPTED TO MIMIC FLOW AFTER THE PROCEDURE AND IT SEEMS AS IF THE AIR FLOW SENSOR IS NOT WORKING PROPERLY ON THIS SPECIFIC CATHETER.

    Patient problems: Insufficient Information

    MAUDE report 13885980 ↗

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Sources and updates

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