Recall Z-0143-2027 · FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
| Date | Oct 9, 2026 (initiated Sep 10, 2026) |
| Status | Open, Classified |
| Reason | Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration. |
| Root cause | Under Investigation by firm |
| Action | On September 10, 2026, Urgent Medical Device Removal letters were sent to customers. Actions to be taken: 1. Immediately stop further use or distribution and segregate affected product (see Attachment 1 for identification of the affected devices). 2. Continue to follow the standard of care when monitoring patients treated with the product. 3. Complete and return the enclosed Reply Verification Tracking Form per the included instructions. 4. Return product to Boston Scientific in accordance with the enclosed instructions. 97657220-FA Advanix Pancreatic LW Pusher. 5. Forward this notice to relev |
| Quantity | 403 |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD, NC, NH, NM, NY, RI, TX, WA, WI, WV and the countries in TBD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223592 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers Boston Scientific Corporation, Dec 29, 2022 |