{
  "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": {
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  "results": [
    {
      "cfres_id": "189622",
      "product_res_number": "Z-0210-2022",
      "event_date_initiated": "2021-09-29",
      "event_date_created": "2021-11-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2025-02-13",
      "res_event_number": "88817",
      "product_code": "NEY",
      "product_description": "Covidien Emprint Ablation Catheter with\nThermosphere Technology Bronchoscopic Ablation, CFN CA108L1",
      "code_info": "Lot 516840",
      "firm_fei_number": "1282497",
      "recalling_firm": "Covidien Llc",
      "address_1": "15 Hampshire St",
      "city": "Mansfield",
      "state": "MA",
      "postal_code": "02048-1113",
      "additional_info_contact": "Bryan Dannettell\n303-530-6227",
      "reason_for_recall": "The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.",
      "root_cause_description": "Process control",
      "action": "Beginning September 29, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to immediately quarantine and discontinue use of the affected products. Customers should return affected product to the firm. If product has been further distributed, please forward the recall information. Customers should complete and return the accompanying response form even if they do not have product on hand.",
      "product_quantity": "14 units",
      "distribution_pattern": "No domestic distribution. Foreign distribution to Hong Kong and UK.",
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        "device_name": "System, Ablation, Microwave And Accessories",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2"
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    }
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}