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.

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

All consignees were sent a copy of the customer notification letter via Federal Express Priority Overnight mail on 09/16/2020. The notification instructs the customer to check their inventory, remove any affected product from their inventory, and return it to BSC. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry. The returned products will be quarantined until an appropriate course of action has been determined. BSC will notify FDA of this decision prior to its implementation.