{
  "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": [
    {
      "status": "Terminated",
      "city": "Louisville",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77623",
      "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": "US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX",
      "recall_number": "Z-2755-2017",
      "product_description": "Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag.  Medtronic Navigation, Inc. Louisville, CO  80027",
      "product_quantity": "214 units",
      "reason_for_recall": "Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.",
      "recall_initiation_date": "20170607",
      "center_classification_date": "20170721",
      "termination_date": "20180629",
      "report_date": "20170802",
      "code_info": "Lot Numbers:  211158059, 211560973, 211959879, 12473141, 212707035, 211158151, 211594328, 211977586, 212503634, 212745660, 211158152, 211599898, 211987873, 212504463, 212796559, 211181212, 211628257, 212127654, 212549456, 212912501, 211181547,211908695, 212141557,  212553428, 211184941, 211916062, 212148368, 212632884,211555011, 211926889, 212434500, 212647830, 211555017, 211950736, 212438405, 212701679"
    }
  ]
}