Class IIDeviceOngoing

Boston Scientific Corporation

NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;

Reason for recall

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.

Details

Recall number: Z-0143-2027
Event ID: 99829
Recall initiated: Sep 10, 2026
Classified: Oct 9, 2026
Reported: Oct 21, 2026
Quantity: 403
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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Marlborough, MA, United States
Lot / code info: Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;