{"recall":{"id":"fda-device-98974","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT","firm":"Boston Scientific Neuromodulation Corporation","date":"2026-06-17","reported":"2026-08-12","status":"Ongoing","classification":"Class I","products":[{"name":"INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.","code":"Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.","quantity":"1079","number":"Z-2879-2026","classification":"Class I"}],"reason":"Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"US: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina","nationwide":false,"states":["NY"],"units":"1079","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=98974","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"4a190ab0092ce4c8","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=98974","record":[{"status":"Ongoing","city":"Valencia","state":"CA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"98974","recalling_firm":"Boston Scientific Neuromodulation Corporation","address_1":"25155 Rye Canyon Loop","address_2":"","postal_code":"91355-5004","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina","recall_number":"Z-2879-2026","product_description":"INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500;   INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700.  part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.","product_quantity":"1079","reason_for_recall":"Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.","recall_initiation_date":"20260617","center_classification_date":"20260805","report_date":"20260812","code_info":"Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638.  All unused products.","more_code_info":""}]}}