{
  "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": "189396",
      "product_res_number": "Z-0077-2022",
      "event_date_initiated": "2021-09-07",
      "event_date_created": "2021-10-08",
      "recall_status": "Open, Classified",
      "res_event_number": "88721",
      "product_code": "PRL",
      "pma_numbers": [
        "P160021"
      ],
      "product_description": "Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS,  REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:",
      "code_info": "Serial Numbers: 22753580",
      "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": "Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain  a 9mm x 29 mm x 135 cm device.",
      "root_cause_description": "Component change control",
      "action": "On September 9, 2021, Gore issued a \"Urgent Field Safety Notice\" to affected consignees  via E-Mail. In addition to informing consignees about the recalled product, Gore asked consignees to take the following actions: \n\n1. Identify and return the device listed in the CHANNEL PARTNER RESPONSE FORM if\nunused.\n\n2. Please complete and sign the enclosed CHANNEL PARTNER RESPONSE FORM and return\nto FieldActionTeam@wlgore.com within 2 weeks of receipt of this notification.\n\n3. Please share this letter with others in your hospital or clinic as appropriate.\n\n4. If a listed device has been implanted, there is no patient-follow up needed and there are\nno further actions needed other than informing Gore the device was used. Please\nindicate the used device on the CHANNEL PARTNER RESPONSE FORM and return to\nFieldActionTeam@wlgore.com within 2 weeks of receipt of this letter. No further action is\nneeded.\n\n5. Any adverse event involving the GORE VIABAHN VBX Balloon Expandable\nEndoprosthesis should be reported to the manufacturer and the country specific\nregulatory authorities immediately. To report an event to W. L. Gore & Associates, email:\nmedcomplaints@wlgore.com or contact:\nEMEA: +49 89 4612 3440, Fax: +49 89 4612 43440\n\n6. This notice needs to be passed on to all those who need to be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). Please transfer this notice to other organization(s) on which this action has an impact (as appropriate).",
      "product_quantity": "2 units",
      "distribution_pattern": "International distribution to the countries of Italy & Lebanon.",
      "openfda": {
        "pma_number": [
          "P160021",
          "P120003",
          "P160024"
        ],
        "registration_number": [
          "3002807314",
          "2134244",
          "2011171",
          "3011175548",
          "3009937642",
          "1018233",
          "3005580113",
          "9616666",
          "2017233",
          "3006082230",
          "2020394",
          "1220477"
        ],
        "fei_number": [
          "3002807314",
          "2011171",
          "3011175548",
          "3009937642",
          "1018233",
          "3003407487",
          "3005580113",
          "2017233",
          "3006082230",
          "3008906816",
          "2020394",
          "1220477"
        ],
        "device_name": "Iliac Covered Stent, Arterial",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}