Recall Z-0322-2022 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
| Date | Oct 21, 2021 |
| Status | Open, Classified |
| Reason | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
| Root cause | Device Design |
| Action | Boston Scientific issued Urgent Medical Device Removal Letter to US consignees via Federal Express Priority Overnight mail on October 21, 2021. Letter states reason for recall, health risk and action to take: Cease further distribution or use of any remaining product affected by this removal immediately. Verify by product lot/batch number in the product table whether any product within your inventory is affected. If so, indicate on your Reply Verification Tracking Form the quantity of units from each lot/batch that you will be returning. If you identify any product from the affected lots/batc |
| Distribution | US Nationwide 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 |