Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890 Recalled by Boston Scientific Corporation Due to RX tunnel component (black sheath) may detach from...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected 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.
Quantity: 15,062 devices distributed in US. 12,930 distributed OUS
Why Was This Recalled?
RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report