{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "West Chester",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64404",
      "recalling_firm": "Atricure Inc",
      "address_1": "6217 Centre Park Drive",
      "address_2": "N/A",
      "postal_code": "45069",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide Distribution including the states of MD, PA and TX.",
      "recall_number": "Z-0912-2013",
      "product_description": "Atricure Inc., Max1  Isolator Transpolar Pen.  Model A000163.  Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.",
      "product_quantity": "5 devices",
      "reason_for_recall": "Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.",
      "recall_initiation_date": "20130114",
      "center_classification_date": "20130306",
      "termination_date": "20130611",
      "report_date": "20130313",
      "code_info": "Model Number(s): MAX1 A000163, Lot Number 41865"
    }
  ]
}