{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "150965",
      "product_res_number": "Z-0698-2017",
      "event_date_initiated": "2016-11-09",
      "event_date_created": "2016-12-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-12-20",
      "res_event_number": "75632",
      "product_code": "PAX",
      "product_description": "Elana Surgical KitHUD\nThe Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity",
      "code_info": "Manufacturers Product Number, 801-H  Lot/Serial Number, 160301",
      "firm_fei_number": "3006784599",
      "recalling_firm": "Elana, Inc.",
      "address_1": "10480 Little Patuxent Pkwy Ste 400 10480 Little Patuxent Pkwy",
      "address_2": "Ste 400",
      "city": "Columbia",
      "state": "MD",
      "postal_code": "21044-3576",
      "reason_for_recall": "Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD due to potentially compromised integrity of the outer sterile packaging of the Elana Catheter 2.0.",
      "root_cause_description": "Packaging",
      "action": "Elana sent an Urgent Medical Device Recall letter dated November 7, 2016, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to not use the affected device and to return the product for replacement.  Customers were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return and exchange.  Customers with questions were instructed to call 301-215-7010.",
      "product_quantity": "4",
      "distribution_pattern": "Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.",
      "openfda": {
        "device_name": "Surgical Kit",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "f"
      }
    }
  ]
}