{
  "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": "25301",
      "product_res_number": "Z-0351-03",
      "event_date_initiated": "2002-11-11",
      "event_date_created": "2015-06-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-07-02",
      "res_event_number": "25150",
      "product_code": "74",
      "k_numbers": [
        "K013392"
      ],
      "product_description": "Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47",
      "code_info": "Lot number 2002080004",
      "firm_fei_number": "3003368396",
      "recalling_firm": "Medtronic Cardiac Surgery Technologies",
      "address_1": "7601 Northland Drive",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55428",
      "reason_for_recall": "The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device.",
      "root_cause_description": "Other",
      "action": "A letter dated November 11, 2002 was sent to the affected consignees who were requested to quarantine any unused pens for retrieval by Medtronic representatives.",
      "product_quantity": "148 pens",
      "distribution_pattern": "All of the consignees were in foreign countries in Europe, Asia and Latin America.",
      "openfda": {}
    }
  ]
}