Boston Scientific NaviFlex LW Pusher and Advx Panc Stent
The device was incorrectly manufactured with a guidewire exit port, which is not a design feature.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Boston Scientific Corporation recalled the NaviFlex LW Pusher because the device was incorrectly manufactured with a guidewire exit port, which is not a design feature associated with this device configuration. The company began the recall on September 10, 2026, and the FDA added it to the Enforcement Report on October 9, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
- UDI-DI
- 08714729856191
- Lot
- 38904309
- 39017263
- 39365322
Details
- Company began the recall
- Event ID
- 99829
- Company
- Boston Scientific Corporation
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
