{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94014",
      "recalling_firm": "Biosense Webster, Inc.",
      "address_1": "31 Technology Dr Ste 200",
      "address_2": "N/A",
      "postal_code": "92618-2302",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution including in the states of FL, IL, AL, NY, PA, SC, AZ, MI KY, NJ, WI, IN, LA, TX, MA, OH, AR, MT, MO, VA, NC, TN, CA, MN, WV, CT, CO, IA, MD, ID, NM, NH, UT, GA, WA, NV, OK, KS, AK, NE, HI.",
      "recall_number": "Z-1290-2024",
      "product_description": "CARTO VIZIGO Bi-Directional Guiding Sheath,  REF D128502    The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180¿ and counterclockwise = 180¿. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO\" 3 Systems.",
      "product_quantity": "853 units",
      "reason_for_recall": "Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.",
      "recall_initiation_date": "20240216",
      "center_classification_date": "20240313",
      "report_date": "20240320",
      "code_info": "Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282"
    }
  ]
}