{
  "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": "Saint Paul",
      "address_1": "651 Campus Dr",
      "reason_for_recall": "The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.",
      "address_2": "",
      "product_quantity": "30",
      "code_info": "107046, 106992, 106993, 106990.",
      "center_classification_date": "20150320",
      "distribution_pattern": "Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.",
      "state": "MN",
      "product_description": "Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125.    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": "20150401",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Cardiovascular Systems, Inc.",
      "recall_number": "Z-1290-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "70727",
      "termination_date": "20160426",
      "more_code_info": "",
      "recall_initiation_date": "20150304",
      "postal_code": "55112-3495",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}