{
  "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": "Louisville",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74096",
      "recalling_firm": "Medtronic Navigation, Inc.",
      "address_1": "826 Coal Creek Cir",
      "address_2": "N/A",
      "postal_code": "80027-9710",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.",
      "recall_number": "Z-1672-2016",
      "product_description": "Visualase Cooled Laser Applicator System (VCLAS). The VCLAS  system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS).      The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.",
      "product_quantity": "120",
      "reason_for_recall": "Potential for  the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.",
      "recall_initiation_date": "20160509",
      "center_classification_date": "20160516",
      "termination_date": "20161219",
      "report_date": "20160525",
      "code_info": "All lot numbers manufactured by BioTex are affected for Model Numbers:   T03: 001-4003 - VCLAS 001-4003 .4mm CORE FIBER 3mm TIP  T10: 001-4000 - VCLAS 001-4000 .4mm CORE FIBER 10mm TIP  T15: 001-6000 - VCLAS 001-6000 .6mm CORE FIBER 15mm TIP"
    }
  ]
}