Boston Scientific Corporation: Stents, Drains And Dilators For The Biliary Ducts
Recall Summary Boston Scientific is recalling certain NaviFlex LW Pusher and Advx Pancreatic Stents used for biliary duct procedures because some units were incorrectly manufactured with a guidewire exit port that shouldn't be on this device model. The affected products were distributed nationwide across multiple U.S. states. This is a Class II recall, meaning the devices could cause serious health problems but are unlikely to cause death.
- Recalling firm
- Boston Scientific Corporation
- Product
- NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ec1155a4-45cd-4375-998c-713108c66965