{
  "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": "CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which  have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.",
      "address_2": "",
      "product_quantity": "27",
      "code_info": "Lot s:  59887, 59888, 61516, and 61517.",
      "center_classification_date": "20120709",
      "distribution_pattern": "Nationwide distribution including CA, FL, IL,  MI, MN, PA, and TX.",
      "state": "MN",
      "product_description": "CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S.  Sterilized with Ethylene Oxide.  The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system.    The Stealth 360-degree 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.",
      "report_date": "20120718",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Cardiovascular Systems, Inc.",
      "recall_number": "Z-1959-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62406",
      "termination_date": "20120719",
      "more_code_info": "",
      "recall_initiation_date": "20120618",
      "postal_code": "55112-3495",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}