{
  "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": [
    {
      "status": "Terminated",
      "city": "Rancho Cordova",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76885",
      "recalling_firm": "Volcano Corporation",
      "address_1": "2870 Kilgore Rd",
      "address_2": "N/A",
      "postal_code": "95670-6133",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distribution to US and Japan",
      "recall_number": "Z-1775-2017",
      "product_description": "Refinity Rotational Intravascular Ultrasound (IVUS) Catheter;  Product number: 400-0200.289; Catalog number 89800.      Cardiovascular:  The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.",
      "product_quantity": "718 total units",
      "reason_for_recall": "High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter.  Kinking could result in disruption of normal clinical workflow or loss of imaging.",
      "recall_initiation_date": "20170329",
      "center_classification_date": "20170413",
      "termination_date": "20170621",
      "report_date": "20170419",
      "code_info": "Lot # 50068951, Expiry date 06/30/2018;  Lot # 50068952, Expiry date 06/30/2018;  Lot # 50069133, Expiry date 06/30/2018;  Lot # 50083387, Expiry Date 11/30/2018;  Lot # 50083390, Expiry Date 11/30/2018.",
      "more_code_info": ""
    }
  ]
}