Recall Z-0286-2021 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
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.
| Date | Sep 16, 2020 |
| Status | Open, Classified |
| Reason | RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. |
| Root cause | Vendor change control |
| Action | 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 |
| Quantity | 15,062 devices distributed in US. 12,930 distributed OUS |
| Distribution | Worldwide distribution - US Nationwide and International distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130484 | MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER Boston Scientific Corp, Aug 9, 2013 |