{
  "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": "73098",
      "recalling_firm": "Spectranetics Corp.",
      "address_1": "9965 Federal Dr",
      "address_2": "N/A",
      "postal_code": "80921-3617",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide distribution to Florida, North Carolina and Pennsylvania.",
      "recall_number": "Z-0758-2016",
      "product_description": "2.3mm Turbo-Power OTW, Manual, Model No 423-050  Product Usage\tThe Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300\" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300\" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300\" Excimer Laser System.",
      "product_quantity": "8 units",
      "reason_for_recall": "The product is labeled with an expiration date that is past its shelf life.",
      "recall_initiation_date": "20160115",
      "center_classification_date": "20160205",
      "termination_date": "20170302",
      "report_date": "20160217",
      "code_info": "Lot CMP15J28A",
      "more_code_info": ""
    }
  ]
}