Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- NaviFlex LW Pusher; Advx Panc. Stent 4/5F
- Material Number (UPN)M00535030
- Lot codes and dates
- Material Number (UPN)M00535030
- UDI-DI08714729856191
- Lot Number
389043093901726339365322
- Amount recalled
- 403
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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