{
  "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": "Colorado Springs",
      "address_1": "9965 Federal Drive",
      "reason_for_recall": "Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.",
      "address_2": "",
      "product_quantity": "3,141 units",
      "code_info": "FDD16D20A; FDD16E02A; FBM16D15B; FBM16F17A; FHH16D05B; FHH16G13A  FHH16D12A; FHH16G22A; FHH16D19A; FHH16H05A; FHH16D26A; FHH16H08C  FHH16D27A; FHH16H12A; FHH16E03A; FHH16H15A; FHH16E13A; FHH16H17A  FHH16E16A; FHH16H24A; FHH16F03A; FHH16H29A; FHH16F07A; FHH16J19A  FHH16F22A ; FHH16J29A; FHH16F28A; FTT16D07A; FTT16F24A; FTT16E23A; FTT16H04A; FTT16F01A; FTT16J09A; FUU16E18A; FUU16F30A; FUU16F08A; FBB16D18A; FBB16H03A; FBB16F01A; FBB16H03B; FBB16G11A; FBB16H26A  FBB16G20A; FLL16G21A; FHH16G28A; FHH16J09B",
      "center_classification_date": "20161201",
      "distribution_pattern": "Worldwide Distribution - US (nationwide and PR)  Internationally  to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.",
      "state": "CO",
      "product_description": "ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009  The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.",
      "report_date": "20161207",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Spectranetics Corporation",
      "recall_number": "Z-0662-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75617",
      "termination_date": "20170418",
      "more_code_info": "",
      "recall_initiation_date": "20161031",
      "postal_code": "80921-3617",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}