{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221149",
      "product_res_number": "Z-2753-2026",
      "event_date_initiated": "2026-06-11",
      "event_date_posted": "2026-07-17",
      "recall_status": "Open, Classified",
      "res_event_number": "99251",
      "product_code": "QZI",
      "pma_numbers": [
        "P230030",
        "P230030S012"
      ],
      "product_description": "FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter",
      "code_info": "GTIN/UDI 00810087180126, Serial Numbers:  1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.",
      "firm_fei_number": "2124215",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5700",
      "additional_info_contact": "Clara Johnson\n651-494-1133",
      "reason_for_recall": "Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Boston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Recall notice to its consignees out side the US on 6/11/2026 via hand delivered letter.  The notice explained the issue and requested the following actions be taken:  \nInstructions:  \n2- Allow Boston Scientific representative(s) to replace affected FARASTAR PFA generators.  \n3- Please complete the attached Verification Form even if you do not have any product to return and send it to your local Boston Scientific office  \n4- If you have products to return, please package them in an appropriate shipping box.  \nAfter receipt of the Verification Form, Boston Scientific will contact you to arrange return.  \n6- Please pass this notice to any health professional from your organization that needs to be aware, and to any organization where the potentially affected devices have been transferred (if appropriate). Please provide Boston Scientific with details of any affected devices that have been transferred to other organizations (if appropriate).  \nThe National Competent Authority has been informed of this communication.",
      "product_quantity": "6 units",
      "distribution_pattern": "International distribution in the countries of Italy, Austria, France, Germany, Belgium.",
      "openfda": {
        "device_name": "Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
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          "P240006",
          "P230017",
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