{
  "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": "Carlsbad",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85197",
      "recalling_firm": "Acutus Medical Inc",
      "address_1": "2210 Faraday Ave Ste 100",
      "address_2": "N/A",
      "postal_code": "92008-7225",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: CA,SC, AZ  OUS: None",
      "recall_number": "Z-1771-2020",
      "product_description": "Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly",
      "product_quantity": "5 units",
      "reason_for_recall": "It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.",
      "recall_initiation_date": "20200225",
      "center_classification_date": "20200423",
      "termination_date": "20210427",
      "report_date": "20200429",
      "code_info": "Affected Lot Numbers/Expiration Date:  19101020 /October 2020"
    }
  ]
}