{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "35749",
      "product_res_number": "Z-0207-05",
      "event_date_initiated": "2004-10-20",
      "event_date_posted": "2004-11-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-01-24",
      "res_event_number": "30369",
      "product_code": "DTA",
      "pma_numbers": [
        "P930039S009"
      ],
      "product_description": "Medtronic CapSureFix Novus Lead Model 5076.",
      "code_info": "Model 5076 45 cm leads (PJN631011V and PJN631012V)",
      "firm_fei_number": "2182208",
      "recalling_firm": "Medtronic Inc. Cardiac Rhythm Managment",
      "address_1": "7000 Central Ave Ne",
      "city": "Fridley",
      "state": "MN",
      "postal_code": "55432",
      "reason_for_recall": "A specific lot of leads are labeled incorrectly.  The leads are 45 cm in length and labeled as 52 cm lead length.",
      "root_cause_description": "Other",
      "action": "Letter of October 20, 2004, to direct customers, advised them to work with their respective Medtronic representatives to locate all leads and return them to Medtronic.",
      "product_quantity": "35 incorrectly labeled leads were distributed to customers.",
      "distribution_pattern": "Leads were distributed to 21 consignees (hospitals/clinics)  throughout the US.",
      "openfda": {
        "k_number": [
          "K022360",
          "K050884",
          "K791380",
          "K073230",
          "K033613",
          "K790503",
          "K812104",
          "K933069",
          "K163008",
          "K101982"
        ],
        "pma_number": [
          "P980023"
        ],
        "registration_number": [
          "2182208",
          "2135338",
          "1047843",
          "9610139",
          "2017865",
          "3009265194",
          "9681449",
          "3017636737",
          "1056553",
          "1028232"
        ],
        "fei_number": [
          "2182208",
          "1047843",
          "3002806500",
          "3007486998",
          "2017865",
          "3005700659",
          "3009265194",
          "1000132370",
          "3017636737",
          "1028232"
        ],
        "device_name": "Tester, Pacemaker Electrode Function",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3720",
        "device_class": "2"
      }
    }
  ]
}