{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "190089",
      "product_res_number": "Z-0290-2022",
      "event_date_initiated": "2021-10-15",
      "event_date_created": "2021-11-24",
      "recall_status": "Open, Classified",
      "res_event_number": "88951",
      "product_code": "MIH",
      "pma_numbers": [
        "P100021"
      ],
      "product_description": "Endurant Stent Graft System\nREF/Description:\nENTF2525C70EE\tSTENT GRAFT ENTF2525C70EE ENDURANT TUBE",
      "code_info": "Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE\nGTIN Code: 00763000006129\nSerial Numbers:\nV30624638\nV30624639",
      "firm_fei_number": "3005364322",
      "recalling_firm": "Medtronic Vascular, Inc.",
      "address_1": "3850 Brickway Blvd",
      "city": "Santa Rosa",
      "state": "CA",
      "postal_code": "95403-8223",
      "additional_info_contact": "Medtronic Customer Service\n888-283-7868",
      "reason_for_recall": "During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube",
      "root_cause_description": "Under Investigation by firm",
      "action": "On or about 10/15/2021, the firm initiated a global verbal notification to customers informing them that is the potential for a specific subset of 18Fr Stent Graft Systems to have the potential for the spindle to detach from the spindle hypotube during deployment.  On 10/18/2021, the firm sent an \"URGENT MEDICAL DEVICE RECALL\" Notification Letter via UPS 2-day delivery.\n\nCustomers are instructed to take the following actions:\n1) Return all unused affected devices to the Recalling Firm via their sales representative or calling customer service at 1-888-283-7868 or email rs.aorticorders@medtronic.com.\n2) Complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com.\n3) Forward this Recall notice to all those who need to be aware within their organization to include physician implanters (US only). Additionally, if any affected devices have been distributed to other organizations, forward this notice to those entities.\n\nFor questions or assistance - contact their Field Representative or Customer Service at 888-283-7868 or email rs.recalls@medtronic.com.",
      "product_quantity": "2 devices",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.",
      "openfda": {
        "pma_number": [
          "P100040",
          "P100021",
          "P070016",
          "P070027",
          "P210032",
          "P990020",
          "P020018",
          "P040043",
          "P140016",
          "P070007",
          "P180001",
          "P990017",
          "P150002",
          "P200030",
          "P190015",
          "P040002",
          "P120006",
          "P110038",
          "P110032",
          "P200045",
          "P020004"
        ],
        "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3002807314",
          "1054811",
          "1219313",
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          "1721676",
          "3009526575",
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          "9612164",
          "9680271",
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        ],
        "fei_number": [
          "3003528016",
          "3002807314",
          "3002534070",
          "1219313",
          "3008307705",
          "1721676",
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          "1000135961",
          "3002806434",
          "3002808486",
          "3008011247",
          "3009380063",
          "3007530363",
          "3005580113",
          "3013164176",
          "1721686",
          "3012102437",
          "3007284313",
          "3007738736",
          "1000114185",
          "2017233",
          "3004497303",
          "3005562917",
          "3016521833",
          "3011063223",
          "3003678543",
          "3001452571",
          "1820334",
          "3003259710",
          "3000206435"
        ]
      }
    }
  ]
}