{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Colorado Springs",
      "address_1": "9965 Federal Drive",
      "reason_for_recall": "Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.",
      "address_2": "",
      "product_quantity": "873 units",
      "code_info": "FMN16E11A; FMN16E18A; FMN16E25A; FMN16F01A; FMN16F08A; FMN16F15A  FMN16F22A; FMN16G13A; FMN16G19A; FMN16G25A; FMN16H04A; FMN16H23A; FMN16J27A",
      "center_classification_date": "20161201",
      "distribution_pattern": "Worldwide Distribution - US (nationwide and PR)  Internationally  to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.",
      "state": "CO",
      "product_description": "Bridge Occlusion Balloon. Model: 590-001  Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.",
      "report_date": "20161207",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Spectranetics Corporation",
      "recall_number": "Z-0663-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75617",
      "termination_date": "20170418",
      "more_code_info": "",
      "recall_initiation_date": "20161031",
      "postal_code": "80921-3617",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}