{
  "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": "122638",
      "product_res_number": "Z-0187-2014",
      "event_date_initiated": "2013-10-11",
      "event_date_posted": "2013-11-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-06-09",
      "res_event_number": "66574",
      "product_code": "OAD",
      "pma_numbers": [
        "P110016S003"
      ],
      "product_description": "Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO.\n\nIntended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.",
      "code_info": "Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.",
      "firm_fei_number": "3005334138",
      "recalling_firm": "St. Jude Medical",
      "address_1": "5050 Nathan Ln N",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55442-3209",
      "additional_info_contact": "Rachel Ellingson\n651-756-5400",
      "reason_for_recall": "St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.",
      "root_cause_description": "Process change control",
      "action": "Consignees were sent a St. Jude Medical \"Urgent Medical Device Notice\" dated 11 October 2013.  The letter was addressed to Cath lab manger / Risk Manger.  The letter described the problem and the product involved in the recall. The letter stated that it is acceptable to continue using these devices as long  as the product is used in accordance with the IFU.",
      "product_quantity": "46",
      "distribution_pattern": "Nationwide Distribution including the states of KY, OH, TX, MA, and NC.",
      "openfda": {
        "pma_number": [
          "P110016",
          "P950005",
          "P050024",
          "P040042",
          "P150005",
          "P020025",
          "P030031",
          "P060019",
          "P010068"
        ],
        "registration_number": [
          "3008452825",
          "3019807891",
          "2030404",
          "1000121056",
          "3012520654",
          "3005334138",
          "2032112",
          "2032098",
          "9673241",
          "1319639",
          "3008328679",
          "1721983",
          "3008093809",
          "3002807314",
          "3017060084",
          "3010280625",
          "1643817",
          "3001592626",
          "3015537323",
          "9681260",
          "3012179728",
          "3004859241",
          "3006634485",
          "1928237",
          "3001763079",
          "3004016520",
          "3010653929",
          "3010273872",
          "3011120183",
          "2028523",
          "3007695959",
          "2182269",
          "9612164",
          "2184149",
          "3009243923",
          "3012260771",
          "3013403214",
          "2182208",
          "3016245399",
          "1721686",
          "3004105270",
          "2124215",
          "3013581838",
          "1650907",
          "3000279201",
          "3010705768",
          "3010291427",
          "3007029079",
          "1721504",
          "3013300026",
          "3012552532",
          "9680001"
        ],
        "fei_number": [
          "3008452825",
          "3019807891",
          "1000121056",
          "3012520654",
          "3002806434",
          "3002681132",
          "3005334138",
          "3003076831",
          "3008328679",
          "1000139754",
          "3008093809",
          "3002807314",
          "3017060084",
          "3010280625",
          "1643817",
          "3001592626",
          "3015537323",
          "3012179728",
          "3003248396",
          "3004859241",
          "3006634485",
          "1928237",
          "3001763079",
          "3004016520",
          "3010653929",
          "3010273872",
          "3011120183",
          "1000064530",
          "3007695959",
          "2182269",
          "1000138054",
          "3009243923",
          "3002808445",
          "3012260771",
          "3013403214",
          "2182208",
          "3016245399",
          "1721686",
          "3004105270",
          "2124215",
          "1000125147",
          "1000519796",
          "3013581838",
          "3000279201",
          "3002806565",
          "3010705768",
          "3010291427",
          "3003058448",
          "3007029079",
          "1721504",
          "3013300026",
          "3012552532"
        ],
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}