{
  "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": [
    {
      "status": "Terminated",
      "city": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76352",
      "recalling_firm": "Cardiovascular Systems Inc",
      "address_1": "1225 Old Highway 8 NW",
      "address_2": "N/A",
      "postal_code": "55112-6416",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution to LA, MS, SC, TX",
      "recall_number": "Z-1230-2017",
      "product_description": "DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145  Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs    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.    The Stealth 360 Orbital PAD 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.",
      "product_quantity": "8 units",
      "reason_for_recall": "CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.",
      "recall_initiation_date": "20161207",
      "center_classification_date": "20170222",
      "termination_date": "20170323",
      "report_date": "20170301",
      "code_info": "Lot:  171686, Expiration:  2018-09-30"
    }
  ]
}