{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "177080",
      "product_res_number": "Z-0576-2020",
      "event_date_initiated": "2018-12-07",
      "event_date_created": "2019-11-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-10-27",
      "res_event_number": "84057",
      "product_code": "NWX",
      "pma_numbers": [
        "P050018"
      ],
      "product_description": "Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx.  The firm name on the label is Spectranetics Corporation, Fremont, CA.",
      "code_info": "AngioSculpt PTCA lot #G18090030.",
      "firm_fei_number": "3005462046",
      "recalling_firm": "Spectranetics Corporation",
      "address_1": "5055 Brandin Ct",
      "city": "Fremont",
      "state": "CA",
      "postal_code": "94538-3140",
      "additional_info_contact": "Ms. Lauren Vitelli\n510-933-7900",
      "reason_for_recall": "The incorrect outer carton box was used for the product.",
      "root_cause_description": "Process control",
      "action": "The recalling firm issued an undated Dear Healthcare Professional letter via FedEx informing the consignee of the issue, the risk to health, and the actions to be taken.  Return of the device was requested.",
      "product_quantity": "3 catheters",
      "distribution_pattern": "Distribution was made to IA, MI, and NJ.  There was government distribution.  There was no military/foreign distribution.",
      "openfda": {
        "pma_number": [
          "P230026",
          "P050018",
          "P200041",
          "P950020"
        ],
        "registration_number": [
          "3002807314",
          "9681260",
          "1721676",
          "3000126629",
          "2011171",
          "3015002281",
          "3005462046",
          "1000121056",
          "3003775186",
          "2124215",
          "3002807315",
          "3010273872"
        ],
        "fei_number": [
          "3002807314",
          "3002806565",
          "1721676",
          "3000126629",
          "2011171",
          "3015002281",
          "3005462046",
          "1000121056",
          "3003775186",
          "2124215",
          "3002807315",
          "3010273872"
        ],
        "device_name": "Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}