{
  "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": "Colorado Springs",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77474",
      "recalling_firm": "Spectranetics Corporation",
      "address_1": "9965 Federal Drive",
      "address_2": "N/A",
      "postal_code": "80921-3617",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico  Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands",
      "recall_number": "Z-2863-2017",
      "product_description": "Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters   Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions",
      "product_quantity": "N/A",
      "reason_for_recall": "Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.",
      "recall_initiation_date": "20170606",
      "center_classification_date": "20170802",
      "termination_date": "20210708",
      "report_date": "20170809",
      "code_info": "Model Number 414-159 Catheter Diameter 1.4mm,   Model Number 417-156 Catheter Diameter 1.7mm,  and  Model Number 420-159 Catheter Diameter 2.0mm."
    }
  ]
}