{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "197593",
      "product_res_number": "Z-1048-2023",
      "event_date_initiated": "2022-12-14",
      "event_date_posted": "2023-02-01",
      "recall_status": "Open, Classified",
      "res_event_number": "91380",
      "product_code": "MLV",
      "product_description": "GORE CARDIOFORM Septal Occluder, REF: GSX0030A",
      "code_info": "UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406",
      "firm_fei_number": "2017233",
      "recalling_firm": "W L Gore & Associates, Inc.",
      "address_1": "3750 W Kiltie Ln",
      "city": "Flagstaff",
      "state": "AZ",
      "postal_code": "86005-8712",
      "additional_info_contact": "928-864-3600",
      "reason_for_recall": "Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.",
      "root_cause_description": "Employee error",
      "action": "On 12/14/22, recall notices were mailed to customers informing them to take the following actions:\n1) Identify and return any unused devices.\n2) Complete and return the customer response form to to FieldActionTeam@wlgore.com\n3) This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred.\n\nCustomers with questions can contact the firm at MPDCustomerCare@wlgore.com",
      "product_quantity": "14",
      "distribution_pattern": "US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.",
      "openfda": {
        "pma_number": [
          "P000049",
          "P120021",
          "P040040",
          "P050006",
          "P000039"
        ],
        "registration_number": [
          "3010273872",
          "3007113487",
          "3012179728",
          "1721676",
          "2135147",
          "3014918977",
          "2011171",
          "2183744",
          "3005704822",
          "1928237",
          "2017233"
        ],
        "fei_number": [
          "3010273872",
          "3007113487",
          "3012179728",
          "1721676",
          "3014918977",
          "2011171",
          "2183744",
          "3005704822",
          "1928237",
          "3005334138",
          "2017233"
        ],
        "device_name": "Transcatheter Septal Occluder",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}