Medical DeviceView official recall notice →
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Brand / Firm
Product
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.
Units affected
403
Description
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;