FDA-Device2020-11-04Class II
Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.
Boston Scientific Corporation
Hazard
RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
Sold states
Worldwide distribution - US Nationwide and International distribution.
Affected count
15,062 devices distributed in US. 12,930 distributed OUS
Manufactured in
300 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0286-2021Don't want to check this manually?
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