Recall Z-0143-2027— Boston Scientific Corporation

Name: FDA recall Z-0143-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-10

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2026-09-10. It names one FDA 510(k) clearance: K223592. 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-09-10
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K223592 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and PushersBoston Scientific Corporation·cleared 2022-12-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.