{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "185041",
      "product_res_number": "Z-0879-2021",
      "event_date_initiated": "2020-11-13",
      "event_date_posted": "2021-01-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-07-23",
      "res_event_number": "87014",
      "product_code": "LWS",
      "pma_numbers": [
        "P110042S077"
      ],
      "product_description": "EMBLEM S-ICD Subcutaneous Electrode Model 3501.  Component of implantable cardioverter defibrillator (ICD)",
      "code_info": "All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.",
      "firm_fei_number": "2124215",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N Bldg 3",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5700",
      "additional_info_contact": "United States Technical Services\n800-227-3422",
      "reason_for_recall": "There is potential for fractures which results in the inability to delivery therapy.",
      "root_cause_description": "Device Design",
      "action": "Boston Scientific will communicate worldwide to physician customers via a customer letter.\n\nThe firm notified consignees on December 2, 2020 via customer letter notifications (Dear Healthcare Professional, Dear Healthcare Administrator, and Dear Patient) .\n\nThe customers notified will be as follows:\n\" EMBLEM Electrode Model 3501 implanting physicians/centers and/or following\nphysicians/centers of record for the advisory population. Physicians associated with an advisory device will receive a list of affected model/serials for patients which they have implanted and/or followed or sent to their center.\n\" Centers/facilities with EMBLEM Subcutaneous Electrode Model 3501 inventory in stock.\nBoston Scientific will deliver the notification by hand or email via our sales representatives or deliver the letter via Federal Express, Courier, or email.\nBoston Scientific will reconcile that 100% of the identified customers /customer\nrepresentatives signed for the letter, or the letter has been confirmed to be delivered.  Boston Scientific will post the product advisory letter on our website, within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/productadvisories.html",
      "product_quantity": "47000 units",
      "distribution_pattern": "Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region",
      "openfda": {
        "pma_number": [
          "P010031",
          "P900061",
          "P980016",
          "P880086",
          "P940008",
          "P030035",
          "P970024",
          "P980050",
          "P010012",
          "P830060",
          "P970013",
          "P110042",
          "P030054",
          "P930035",
          "P910023",
          "P910073",
          "P890061",
          "P910077",
          "P880006",
          "P980049",
          "P050023",
          "P950022",
          "P960040",
          "P920015",
          "P980023",
          "P940024",
          "P220012"
        ],
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
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          "3005700659",
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          "3002618605",
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}