{
  "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": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68806",
      "recalling_firm": "Cardiovascular Systems, Inc.",
      "address_1": "651 Campus Dr",
      "address_2": "N/A",
      "postal_code": "55112-3495",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and  TX.",
      "recall_number": "Z-2155-2014",
      "product_description": "CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003.    The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.",
      "product_quantity": "48",
      "reason_for_recall": "CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture,  and release particulate during use.",
      "recall_initiation_date": "20140523",
      "center_classification_date": "20140814",
      "termination_date": "20141001",
      "report_date": "20140820",
      "code_info": "100573, 100575, 100674, 100676, 100678, 100680."
    }
  ]
}