{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220311",
      "product_res_number": "Z-2879-2026",
      "event_date_initiated": "2026-06-17",
      "event_date_posted": "2026-08-05",
      "recall_status": "Open, Classified",
      "res_event_number": "98974",
      "product_code": "LGW",
      "pma_numbers": [
        "P030017"
      ],
      "product_description": "INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; \nINFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700.  part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.",
      "code_info": "Model/UDI-DI:\nSC-2317-50/08714729861614,\nSC-2317-70/08714729861638.\n\nAll unused products.",
      "firm_fei_number": "3006630150",
      "recalling_firm": "Boston Scientific Neuromodulation Corporation",
      "address_1": "25155 Rye Canyon Loop",
      "city": "Valencia",
      "state": "CA",
      "postal_code": "91355-5004",
      "additional_info_contact": "Renee Archie\n508-683-4523",
      "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.",
      "root_cause_description": "Device Design",
      "action": "On 6/17/2026, removal notices were mailed and emailed to customers informing them of the following:\n\n1) Stop further use or distribution and segregate affected product.\n2) Complete and return the Reply Verification Tracking Form via email to BSCFieldActionCenter@bsci.com\n3) Return affected devices to firm.\n4) Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which these systems may have been transferred.\n\nReport any adverse events or quality concerns associated with use of these devices to firm via email at BSCComplaints@bsci.com\n\nThis removal of unused Infinion CX Leads is part of the planned transition to the next generation lead (Infinion Pro).",
      "product_quantity": "1079",
      "distribution_pattern": "US: NY.\nOUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina",
      "openfda": {
        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
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