{
  "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": "Louisville",
      "address_1": "826 Coal Creek Cir",
      "reason_for_recall": "The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.",
      "address_2": "",
      "product_quantity": "423 devices",
      "code_info": "Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip Lots - 000212782059,  000212823919,  000212894256,  000212978141,  000212783784,  000212854585,  000212926008,  000212996201,  000212823883,  000212882619,  000212956163,  000213145362; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip Lots - 000212354781,  000212656015,  000212760821,  000212913269,  000212384009,  000212660280,  000212827856,  000212922387,  000212465594,  000212664497,  000212838837,  000212935278,  000212507737,  000212698642,  000212846727,  000213000097,  000212510629,  000212715926,  000212856596,  000213001255,  000212624409,  000212745633,  000212873863,  000213009483,  000212626439,  000212753561,  000212873873,  000213041517,  000212632885,  000212756095,  000212879480,  000213056030; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip Lots - 000212141557,  000212503634,  000212647830,  000212796559,  000212148368,  000212504463,  000212701679,  000212846726,  000212434500,  000212549456,  000212707035,  000212901580,  000212438405,  000212553428,  000212745660,  000212912501,  000212473141,  000212632884,  000212795235,  000212963182",
      "center_classification_date": "20171018",
      "distribution_pattern": "US nationwide distribution.",
      "state": "CO",
      "product_description": "VCLAS (Visualase Cooled Laser Ablation System)   Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;  Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip;  Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip",
      "report_date": "20171025",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic Navigation, Inc.",
      "recall_number": "Z-0025-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "77977",
      "termination_date": "20190805",
      "more_code_info": "",
      "recall_initiation_date": "20170727",
      "postal_code": "80027-9710",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}