{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irwindale",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78129",
      "recalling_firm": "Biosense Webster, Inc.",
      "address_1": "15715 Arrow Hwy",
      "address_2": "N/A",
      "postal_code": "91706-2006",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China",
      "recall_number": "Z-0058-2018",
      "product_description": "THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S",
      "product_quantity": "329 units",
      "reason_for_recall": "Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a \"Map: magnetic distortion\" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.",
      "recall_initiation_date": "20170906",
      "center_classification_date": "20171027",
      "termination_date": "20191119",
      "report_date": "20171108",
      "code_info": "17637495L  17638389L  17639706L  17639707L  17639708L  17640039L   17640494L   17640952L  17640040L   17640742L   17640953L  17640041L   17640743L   17640954L  17640490L   17640744L  17643130L  17638118L  17638387L  17638388L"
    }
  ]
}