{
  "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": "Colorado Springs",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85477",
      "recalling_firm": "Spectranetics Corporation",
      "address_1": "9965 Federal Dr",
      "address_2": "N/A",
      "postal_code": "80921-3822",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US:  Nationwide  OUS:  Australia, Austria, Belgium, Canada, Croatia,  Cyprus,  Czech Republic,  Denmark,  Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, The Netherlands, and the United Kingdom of Great Britain and Northern Ireland",
      "recall_number": "Z-2143-2020",
      "product_description": "Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length  80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI:  00813132024666",
      "product_quantity": "N/A",
      "reason_for_recall": "There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations.  All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature.  If left in too long it could lead to embolization.",
      "recall_initiation_date": "20200331",
      "center_classification_date": "20200528",
      "termination_date": "20221031",
      "report_date": "20200603",
      "code_info": "All lots"
    }
  ]
}