Boston Scientific Corporation recalls NaviFlex LW Pusher
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Sep 10, 2026
- Reported
- Oct 21, 2026
- 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.
- Status
- Ongoing
- Quantity
- 403
- Lot / codes
- Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;
- Company location
- Marlborough, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0143-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0143-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.