Device recall

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

FDA recall source

Recall number

Z-0143-2027

Event id

99829

Status

Ongoing

FDA classification

Class II

Recalling firm

Boston Scientific Corporation

Report date

Oct 21, 2026

Posted

Oct 9, 2026

Initiated

Sep 10, 2026

Center classification date

Oct 9, 2026

Product code

FGE

Device type

Stents, Drains And Dilators For The Biliary Ducts

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.

Root cause

Under Investigation by firm

Quantity

403

Code info

Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;

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.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K223592

Location

Marlborough, MA, United States