{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "183678",
      "product_res_number": "Z-0291-2021",
      "event_date_initiated": "2020-09-09",
      "event_date_created": "2020-10-23",
      "recall_status": "Open, Classified",
      "res_event_number": "86421",
      "product_code": "MIH",
      "pma_numbers": [
        "P040043"
      ],
      "product_description": "GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System",
      "code_info": "CATALOG NUMBERS TGM212110X* TGM212115X* TGM212120X* TGM262610X* TGM262615X* TGM262620X* TGM282810X* TGM282815X* TGM282820X* TGM313110X* TGM313115X* TGM313120X* TGM343410X* TGM343415X* TGM343420X* TGM373710X* TGM373715X* TGM373720X* TGM404010X* TGM404015X* TGM404020X* TGM454510X* TGM454515X* TGM454520X* TGM262110X* TGM312610X* TGMR313110X* TGMR313115X* TGMR313120X* TGMR312610X* TGMR373710X* TGMR373715X* TGMR373720X* TGMR404010X* TGMR404015X* TGMR404020X* *X is a placeholder for enumeration code: E=EMEA, Australia, New Zealand; J=Japan  All Lot Numbers",
      "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": "800-528-8763",
      "reason_for_recall": "When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.",
      "root_cause_description": "Process control",
      "action": "On 09/23/2020, the firm sent an \"URGENT Medical Device Safety Correction\" via First Class Postal (USPS) informing them that all lots of its Thoracic Stent Graft Systems may encounter difficulty withdrawing the delivery catheter due to a proximal stent apex being lodged with the delivery catheter leading olive.  Customers are instructed to:\nImmediate Actions for the Recipient:\n- Take note of amendment/reinforcement of Instructions For Use (IFU)\n- Please respond to the enclosed acknowledgement\n- Please share this letter with others in your hospital or clinic as appropriate\nThe Recalling Firm is providing physicians with this information so that appropriate risk-related decisions can be made with the patient when considering the Conformable Thoracic Stent Graft System. The Recalling Firm maintains its confidence in the safety and efficacy of the device and will not be removing the affected products from the market.\n\nThere are no actions required for patients already implanted with the Thoracic Stent Graft.\n\nPlease contact the Recalling Firm's Customer Service (email:\nMPDCustomerCare@wlgore.com or by phone at 800-528-8763) with any questions related to this letter.",
      "product_quantity": "19013 units",
      "distribution_pattern": "U.S. - Nationwide\n\nO.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden,\nSwitzerland, United Arab Emirates, and United Kingdom",
      "openfda": {
        "pma_number": [
          "P070027",
          "P990020",
          "P110038",
          "P120006",
          "P100021",
          "P070007",
          "P070016",
          "P200030",
          "P210032",
          "P040043",
          "P110032",
          "P990017",
          "P020018",
          "P040002",
          "P200045",
          "P100040",
          "P150002",
          "P140016",
          "P020004",
          "P190015",
          "P180001"
        ],
        "registration_number": [
          "2030624",
          "9612164",
          "3009526575",
          "3009380063",
          "3008011247",
          "3013164176",
          "3008307705",
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          "3016521833",
          "9710641",
          "3003678543",
          "3007738736",
          "3005580113",
          "3005562917",
          "2247858",
          "2011171",
          "9680271",
          "1054811"
        ],
        "fei_number": [
          "1000114185",
          "3002806434",
          "3000206435",
          "3009526575",
          "3009380063",
          "3008011247",
          "3013164176",
          "3008307705",
          "3012102437",
          "3001452571",
          "1820334",
          "3003565456",
          "3006131984",
          "3004497303",
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          "1219313",
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          "3002807314",
          "3011324393",
          "3002808486",
          "2017233",
          "1721676",
          "1721686",
          "3016521833",
          "3003678543",
          "3003259710",
          "3007738736",
          "3003528016",
          "3005580113",
          "1000135961",
          "3002534070",
          "3005562917",
          "3007530363",
          "2011171"
        ],
        "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}