{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196192",
      "product_res_number": "Z-0136-2023",
      "event_date_initiated": "2022-09-21",
      "event_date_posted": "2022-10-26",
      "recall_status": "Open, Classified",
      "res_event_number": "90912",
      "product_code": "MLV",
      "product_description": "GORE CARDIOFORM ASD Occluder. cardiovascular implant.",
      "code_info": "Model Numbers: ASD37A\nUDI-DI Codes: 00733132636501\nSerial Numbers:\n24468090\n24468092\n24468093\n24468096\n24468097\n24468098\n24468099\n24468103\n24468104\n24480314\n24480315\n24480316\n24480318\n\n24468102\n24468094\n24468100\n24468101\n24480317\n24468091\n24468095\n\nModel Number: ASD44A\nUDI-DI Code: 00733132636518\nSerial Numbers:\n24281498\n24281499\n24281500\n24281501\n24281502\n24281507\n24281509\n24281511\n24281512\n24429270\n24429271\n24429276\n24429278\n24429279\n24480351\n24480352\n24480353\n24545359\n24550148\n24550149\n24578446\n24578447\n\n24281506\n24429272\n24429273\n24429274\n24429277\n24545360\n24545362\n24550147\n24550150\n24550151\n24578443\n24578445\n24281503\n24281504\n24281505\n24281508\n24281510\n24429275\n24480354\n24480355\n24545358\n\nModel Number: ASD44E\nUDI-DI Code: 00733132636617\nSerial Numbers:\n24305083\n\n24305081\n24550693\n24550694\n24305079\n24305080\n24305082\n24550695\n24550696\n24550697",
      "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": "MPD Customer Care\n800-528-8763",
      "reason_for_recall": "Due to manufacturing records (Release Test Results) indicating \"Failed\".",
      "root_cause_description": "Employee error",
      "action": "Between 09/21-32/2022, the firm sent an \"URGENT MEDICAL DEVICE RECALL/FIELD SAFETY NOTICE\" via FedEx 2nd Day (U.S.), Postal Mail (EMEA), and Personal Delivery (Japan), informing customers that W.L. Gore & Associates (Gore) identified devices that were incorrectly released following a documented failure of a subset of quality tests. A failure of the subset of quality tests could potentially result in increased risks during the release of the device from the delivery system for the affected devices.\n\nCustomer are instructed to:\n Identify and return any unused devices within the scope of this recall.\n Complete and sign the enclosed CUSTOMER RESPONSE FORM and return to\nFieldActionTeam@wlgore.com within 2 weeks of receipt of this notification.\n Share this letter with others in their institution as appropriate. Transfer this\nnotice to other organization(s) as appropriate.\n If a listed device has been used, there is no patient follow-up needed and no further\nactions required other than informing Gore the device was used. Indicate the\nused device(s) on the CUSTOMER RESPONSE FORM and return to\nFieldActionTeam@wlgore.com.\n\nFor questions, contact Gore Customer Service via email - MPDCustomerCare@wlgore.com",
      "product_quantity": "98 units",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan.",
      "openfda": {
        "pma_number": [
          "P040040",
          "P120021",
          "P000049",
          "P050006",
          "P000039"
        ],
        "registration_number": [
          "2135147",
          "3007113487",
          "3014918977",
          "2183744",
          "3012179728",
          "1928237",
          "2017233",
          "2011171",
          "3005704822",
          "1721676",
          "3010273872"
        ],
        "fei_number": [
          "3007113487",
          "3014918977",
          "2183744",
          "3012179728",
          "1928237",
          "3005334138",
          "2017233",
          "2011171",
          "3005704822",
          "1721676",
          "3010273872"
        ],
        "device_name": "Transcatheter Septal Occluder",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}