{
  "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": [
    {
      "country": "United States",
      "city": "Saint Paul",
      "address_1": "651 Campus Dr",
      "reason_for_recall": "Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD).    The device mistakenly contains a saline line that is used in our peripheral atherectomy device.  This saline line was not part of the FDA approval for use in the coronary device.  It therefore does not meet specification for this device. C",
      "address_2": "",
      "product_quantity": "318",
      "code_info": "Lot: 85408 -85412,  85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975 - 88979, 89498, 89501- 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156.",
      "center_classification_date": "20140225",
      "distribution_pattern": "USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.",
      "state": "MN",
      "product_description": "CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125    Product Usage:  The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.",
      "report_date": "20140305",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Cardiovascular Systems, Inc.",
      "recall_number": "Z-1095-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67445",
      "termination_date": "20140505",
      "more_code_info": "",
      "recall_initiation_date": "20140127",
      "postal_code": "55112-3495",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}