{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "159186",
      "product_res_number": "Z-0079-2018",
      "event_date_initiated": "2017-10-04",
      "event_date_created": "2017-11-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-10-15",
      "res_event_number": "78323",
      "product_code": "NIK",
      "pma_numbers": [
        "P960040",
        "P010012"
      ],
      "product_description": "VIGILANT X4 CRT-D, Model G247, Sterile. \n\n Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.",
      "code_info": "Serial numbers 174170, 174349, 174598, and 174606.",
      "firm_fei_number": "2124215",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5700",
      "additional_info_contact": "United States Technical Services\n800-227-3422",
      "reason_for_recall": "The devices have an incorrect firmware configuration.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative.",
      "product_quantity": "4 devices",
      "distribution_pattern": "The devices were distributed to medical facilities located in MN and OH.  There was no foreign/government/military distribution.",
      "openfda": {
        "pma_number": [
          "P000009",
          "P060027",
          "P880006",
          "P010012",
          "P970013",
          "P910023",
          "P050023",
          "P880086",
          "P030035",
          "P030054",
          "P010031"
        ],
        "registration_number": [
          "3008159616",
          "9610139",
          "2032521",
          "3005334138",
          "2017865",
          "3015453963",
          "3013500228",
          "3018094310",
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        ],
        "fei_number": [
          "3008159616",
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          "2017865",
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          "3013500228",
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          "3003120897",
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          "3003574398",
          "1000165971",
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          "3013288201",
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          "3013596024",
          "3033257494",
          "3008377825",
          "2648729",
          "3012552532",
          "3002806603"
        ],
        "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}