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General product and regulatory information for lab, clinic and supply staff. It is not medical advice and not instructions for any procedure.
Short answer
An extraction balloon is a balloon-tipped biliary catheter used through an endoscope to remove stones from the bile duct, and in some designs to inject contrast medium while the balloon blocks the duct. FDA classifies this device under product code GCA (Class 2, 21 CFR 876.5010). The labeling of two manufacturers, Boston Scientific and Cook Medical, both states a latex warning, single use only, and ERCP-specific contraindications.
Definition and scope
FDA’s product classification database lists code GCA as a “biliary catheter for stone removal that may also allow for irrigation and contrast injection.” The entry shows Class 2, regulation number 876.5010, the Gastroenterology/Urology review panel, and no GMP exemption.
The regulation, 21 CFR 876.5010 (“Biliary catheter and accessories”), describes a biliary catheter as a tubular flexible device used for temporary or prolonged drainage of the biliary tract. It classifies these devices as Class II (special controls). Its premarket-notification exemption is worded for a bile collecting bag or a surgical biliary catheter without a balloon component, so the exemption wording itself separates balloon-less catheters from balloon-bearing ones.
This page covers the biliary retrieval device only. The same word “balloon” appears on other catheters; see the misunderstandings section below.
How it is used in practice (what the labeling says)
Labeling states the intended use rather than a technique, and this guide does not reproduce procedure steps. Boston Scientific’s Extractor Pro XL brief summary (document ENDO-472608-AD, November 2025) says the catheter “is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.” Cook Medical’s extraction balloon instructions for use state: “This device is used for endoscopic removal of biliary stones and for contrast injection.”
Both manufacturers limit use to trained clinicians. Boston Scientific refers to physicians thoroughly trained in endoscopic retrograde cholangiopancreatography (ERCP). Cook restricts use to “a trained healthcare professional” and says not to use the device for any purpose other than its stated intended use. Cook names an inflation port, a proximal wire port, an injection port and, depending on configuration, a removable stylet.
Labeling items two manufacturers both state
This comparison keeps only items that appear in both documents. It describes labeling for the two products named, not every extraction balloon on the market.
| Labeling item | Boston Scientific Extractor Pro XL (Nov 2025) | Cook extraction balloon IFU |
|---|---|---|
| Stone removal indication | Remove stones from the biliary system | Endoscopic removal of biliary stones |
| Contrast injection | Facilitate injection of contrast while occluding the duct | Listed for contrast injection |
| Contraindications | Those specific to ERCP and endoscopic sphincterotomy | Those specific to ERCP and procedures performed with balloon stone extraction |
| Natural rubber latex | “Contains Natural Rubber Latex Which May Cause Allergic Reactions” | Contains natural rubber latex; labeling lists latex hypersensitivity as a contraindication |
| Reuse | Single use only; do not reuse, reprocess or resterilize | Single use only; reprocessing may lead to device failure or transmission of disease |
| Listed possible complications | Includes pancreatitis, cholangitis, perforation, hemorrhage, septicemia/infection, allergic reaction, stone impaction | ERCP complications include pancreatitis, cholangitis, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication; balloon extraction adds stone impaction |
The labeling also differs in places. Boston Scientific states a working-channel minimum of 3.2 mm and recommends its own 0.035 in guidewire; Cook directs readers to the package label for the minimum channel size. Check each product’s own current labeling instead of assuming one balloon matches another.
Where it matters for labs, clinics and supply records
- Latex flag. Both documents state that the balloon contains natural rubber latex. A supply record that omits this fact leaves staff without the warning the manufacturers print.
- Single use. Both documents say not to reprocess. That separates the balloon from the reusable accessories and endoscopes described in endoscope reprocessing.
- Prescription device. Boston Scientific’s summary carries the US federal prescription-only statement.
- Endoscope compatibility. Working-channel size is labeled per product (3.2 mm minimum for Extractor Pro XL), so the endoscope in use is part of the specification.
- Regulatory identity. Product code GCA and regulation 876.5010 let a record be matched to FDA’s classification entry.
For companion equipment, see the guides on the sphincterotome and the choledochoscope. Boston Scientific’s contraindications explicitly cite endoscopic sphincterotomy alongside ERCP.
Common misunderstandings
Is an extraction balloon the same as a Foley retention balloon?
No. A Foley catheter’s balloon holds the catheter in place (see catheter balloon sizes). A biliary extraction balloon is used through an endoscope for the bile duct and is classified separately under 876.5010.
Does the exemption in 876.5010 cover all biliary catheters?
No. The regulation’s exemption wording applies to a bile collecting bag or a surgical biliary catheter without a balloon component.
Can a single-use balloon be cleaned and reused?
Both manufacturers’ labeling says no.
FAQ
What is an extraction balloon used for?
The Boston Scientific and Cook labels state endoscopic removal of biliary stones and, for contrast injection, occluding the duct with the balloon.
What FDA product code and regulation apply?
Product code GCA, Class 2, 21 CFR 876.5010, as shown in FDA’s classification database (checked 2026-10-31).
Do extraction balloons contain latex?
The Boston Scientific Extractor Pro XL and the Cook extraction balloon both state that they contain natural rubber latex. Other products may differ, so read each product’s labeling.
Are they sterile and single use?
Boston Scientific states the catheter is supplied sterile and for single use only; Cook states the device is designed for single use only.
Sources
- FDA, Product Classification, code GCA: accessdata.fda.gov (checked 2026-10-31).
- 21 CFR 876.5010, Biliary catheter and accessories: ecfr.gov (checked 2026-10-31).
- Boston Scientific, Extractor Pro XL Retrieval Balloon Catheter brief summary, ENDO-472608-AD, November 2025: bostonscientific.com (checked 2026-10-31).
- Cook Medical, Extraction Balloon instructions for use: ifu.cookmedical.com (checked 2026-10-31).
