NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Official notice from a government agency or its published feed.
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.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · 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.
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.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · 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.
Hazard: 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.
View the FDA enforcement report ↗ ← All reports