{"recall":{"id":"fda-device-99829","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Boston Scientific Corporation recalls NaviFlex LW Pusher","firm":"Boston Scientific Corporation","date":"2026-09-10","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;","code":"Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;","quantity":"403","number":"Z-0143-2027","classification":"Class II"}],"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"403","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99829","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c9ffa3c92f71cd2f","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99829","record":[{"status":"Ongoing","city":"Marlborough","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99829","recalling_firm":"Boston Scientific Corporation","address_1":"100 Boston Scientific Way","address_2":"","postal_code":"01752-1234","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-0143-2027","product_description":"NaviFlex LW Pusher;  Advx Panc. Stent 4/5F;  Material Number (UPN): M00535030;","product_quantity":"403","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.","recall_initiation_date":"20260910","center_classification_date":"20261009","report_date":"20261021","code_info":"Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;","more_code_info":""}]}}