{
  "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": "Fremont",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76400",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "47215 Lakeview Blvd",
      "address_2": "N/A",
      "postal_code": "94538-6530",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US and Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Denmark, Dominican Rep., Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, Russian Fed. ,Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, United Arab Emir.,  Venezuela, Virgin Islands, W.Bank/Gaza Strip",
      "recall_number": "Z-1401-2017",
      "product_description": "AngioJet¿ Ultra 5000 A Console:Foot Switch  Material number (U PN) 105650    Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, total infused saline volume, and Ultra System malfunction warnings.",
      "product_quantity": "3402 units; 2626 in US; 786 units OUS",
      "reason_for_recall": "Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device.",
      "recall_initiation_date": "20170131",
      "center_classification_date": "20170303",
      "termination_date": "20190422",
      "report_date": "20170315",
      "code_info": "Serial number ranges:U2000 - U4530            U5001 - U5233;           U6001 - U6197;            U6300 - U6374 ;           U6376 - U6432;           U8001 - U8276;           U8500 - U8719;            U8800 - U8829;   U8831 - U8869."
    }
  ]
}