TemporaryFDAOngoing
Can cause harm that is usually temporary.
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Check the device or its packaging for
Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;
- Why
- 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.
- Distributed
- 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.
- Company
- Boston Scientific Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0143-2027 · retrieved 9 October 2026
Read the official notice