Boston Scientific Corporation recalls Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930;

Recalled November 4, 2020 · FDA recall Z-0286-2021 · Boston Scientific

Hazard

RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. · FDA Class II

Units

15,062 devices distributed in US. 12,930 distributed OUS

Sold at

Worldwide distribution - US Nationwide and International distribution.

Description

RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.

Product

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.

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →