FDA-Device2014-01-22Class II
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon 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.
Boston Scientific Corporation
Hazard
Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Sold states
Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
Affected count
39 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0710-2014Don't want to check this manually?
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