{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mason",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83021",
      "recalling_firm": "AtriCure, Inc.",
      "address_1": "7555 Innovation Way",
      "address_2": "N/A",
      "postal_code": "45040-9695",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution, and countries of Germany and Netherlands.",
      "recall_number": "Z-1887-2019",
      "product_description": "EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.",
      "product_quantity": "497",
      "reason_for_recall": "The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.",
      "recall_initiation_date": "20190529",
      "center_classification_date": "20190626",
      "termination_date": "20200504",
      "report_date": "20190703",
      "code_info": "Lots 70638, 71332, 89208, 89938, 90624"
    }
  ]
}