{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "170343",
      "product_res_number": "Z-0831-2019",
      "event_date_initiated": "2019-01-22",
      "event_date_created": "2019-02-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-05-12",
      "res_event_number": "81932",
      "product_code": "OCL",
      "k_numbers": [
        "K113475"
      ],
      "product_description": "COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S",
      "code_info": "UDI - 00818354012828 Lot Numbers - All lots within expiry",
      "firm_fei_number": "3011706110",
      "recalling_firm": "AtriCure, Inc.",
      "address_1": "7555 Innovation Way",
      "city": "Mason",
      "state": "OH",
      "postal_code": "45040-9695",
      "additional_info_contact": "John Scott Ehlert\n513-755-4100",
      "reason_for_recall": "There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On January 22, 2019, AtriCure distributed URGENT Advisory Notices to customers via certified mail.  AtriCure is providing modifications to the existing Cobra Fusion Instruction for Use (IFU), to address contributing TE Factors associated with stand-alone off-pump procedures. These are in addition to the warnings and precautions that are present within the current IFU.\n\nModifications to Warnings:\nWhen utilizing the Cobra Fusion device in a stand-alone off-pump (without CPB) procedure, the following should be considered:\n- Physicians should consider a comprehensive anti-coagulation protocol including pre-operative, intra-operative and post-operative anti-coagulation management to prevent potential thromboemboli.\n\nModifications to Precautions:\n- Post-operative anti-coagulation therapy for protection against thromboemboli is inclusive of the bridging period between the end of the procedure and until effective therapeutic levels of Oral Anticoagulation (OAC) are achieved.\n\nCustomers Should Take the following Action:\n- Read and follow the revised Instructions for Use IFU enclosed with the notification letter when using the Cobra Fusion.\n- Report any post ablation thromboembolic event with the Cobra Fusion, to AtriCure by phone at 1-866-349-2342 (select option 6) or e-mail to pcomplaints@atricure.com.\n- Return the completed Acknowledgement Form.\n\nContact Information:\nIf you have any questions, please contact Rob Cantu, Vice President of Quality at (1-513-644-4245) from 9-6pm ET on Mondays - Fridays. You may also contact customer service at (1-866-349-2342) any time of day, your message will be forwarded to Quality Assurance for review promptly.\n\n**Press Release will be issue depended on CDRH comment/review**",
      "product_quantity": "175 units",
      "distribution_pattern": "AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI\n\nInternationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium and Latvia",
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        "device_name": "Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2",
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