{
  "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": "Bloomington",
      "address_1": "750 N Daniels Way",
      "reason_for_recall": "Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting  Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the  inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death,  occurred in cases where a tip separation",
      "address_2": "",
      "product_quantity": "1,057 units in USA",
      "code_info": "REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905  All lots distributed prior to 4/16/2013",
      "center_classification_date": "20130515",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide; in the countries of  Japan,  Europe, Brazil, and Australia",
      "state": "IN",
      "product_description": "Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile    Product Usage:  The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps Preven the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: \u001c Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD . \u001c improve blood flow to the extremity.",
      "report_date": "20130522",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Cook, Inc.",
      "recall_number": "Z-1274-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64975",
      "termination_date": "20131205",
      "more_code_info": "",
      "recall_initiation_date": "20130418",
      "postal_code": "47404-9120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}