{
  "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": "167115",
      "product_res_number": "Z-0007-2019",
      "event_date_initiated": "2018-07-31",
      "event_date_posted": "2018-10-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-04-09",
      "res_event_number": "80812",
      "product_code": "MIH",
      "pma_numbers": [
        "P040002S060",
        "P040002S061"
      ],
      "product_description": "ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: \t\t\t\t\t\t\t\t\t\nBEA22-120/I20-40,\t\t\t\t\nBEA22-100/I20-40,\t\t\t\t\nBEA22-80/I20-40,\t\t\t\t\nBEA22-60/I20-40,\t\t\t\t\nBEA22-40/I20-40,\t\t\t\t\nBEA22-120/I16-40,\t\t\t\t\nBEA22-100/I16-40,\t\t\t\t\nBEA22-80/I16-40,\t\t\t\t\nBEA22-60/I16-40,\t\t\t\t\nBEA22-40/I16-40,\t\t\t\t\nBEA22-120/I13-40,\t\t\t\t\nBEA22-100/I13-40,\t\t\t\t\nBEA22-80/I13-40,\t\t\t\t\nBEA22-60/I13-40,\t\t\t\t\nBEA22-40/I13-40,\t\t\t\t\nBEA22-110/I20-30,\t\t\t\t\nBEA22-90/I20-30,\t\t\t\t\nBEA22-70/I20-30,\t\t\t\t\nBEA22-50/I20-30,\t\t\t\t\nBEA22-110/I16-30,\t\t\t\t\nBEA22-90/I16-30,\t\t\t\t\nBEA22-70/I16-30,\t\t\t\t\nBEA22-50/I16-30,\t\t\t\t\nBEA22-100/I20-55,\t\t\t\t\nBEA22-80/I20-55,\t\t\t\t\nBEA22-100/I16-55,\t\t\t\t\nBEA22-80/I16-55,\t\t\t\t\nBEA25-120/I20-40,\t\t\t\t\nBEA25-100/I20-40,\t\t\t\t\nBEA25-80/I20-40,\t\t\t\t\nBEA25-60/I20-40,\t\t\t\t\nBEA25-40/I20-40,\t\t\t\nBEA25-120/I16-40,\t\t\t\t\nBEA25-100/I16-40,\t\t\t\t\nBEA25-80/I16-40,\t\t\t\t\nBEA25-60/I16-40,\t\t\t\t\nBEA25-40/I16-40,\t\t\t\t\nBEA25-120/I13-40,\t\t\t\t\nBEA25-100/I13-40,\t\t\t\t\nBEA25-80/I13-40,\t\t\t\t\nBEA25-60/I13-40,\t\t\t\t\nBEA25-40/I13-40,\t\t\t\t\nBEA25-110/I20-30,\t\t\t\t\nBEA25-90/I20-30,\t\t\t\t\nBEA25-70/I20-30,\t\t\t\t\nBEA25-50/I20-30,\t\t\t\t\nBEA25-110/I16-30,\t\t\t\t\nBEA25-90/I16-30,\t\t\t\t\nBEA25-70/I16-30,\t\t\t\t\nBEA25-50/I16-30,\t\t\t\t\nBEA25-100/I20-55,\t\t\t\t\nBEA25-80/I20-55,\t\t\t\t\nBEA25-100/I16-55,\t\t\t\t\nBEA25-80/I16-55,\t\t\t\t\nBEA28-120/I20-40,\t\t\t\t\t\t\t\t\nBEA28-100/I20-40,\t\t\t\t\t\t\t\t\nBEA28-80/I20-40,\t\t\t\t\t\t\t\t\nBEA28-60/I20-40,\t\t\t\t\t\t\t\t\nBEA28-40/I20-40,\t\t\t\t\t\t\t\t\nBEA28-120/I16-40,\t\t\t\t\t\t\t\t\nBEA28-100/I16-40,\t\t\t\t\t\t\t\t\nBEA28-80/I16-40,\t\t\t\t\t\t\t\t\nBEA28-60/I16-40,\t\t\t\t\t\t\t\t\nBEA28-40/I16-40,\t\t\t\t\t\t\t\t\nBEA28-120/I13-40,\t\t\t\t\t\t\t\t\nBEA28-100/I13-40,\t\t\t\t\t\t\t\t\nBEA28-80/I13-40,\t\t\t\t\t\t\t\t\nBEA28-60/I13-40,\t\t\t\t\t\t\t\t\nBEA28-40/I13-40,\t\t\t\t\t\t\t\t\nBEA28-110/I20-30,\t\t\t\t\t\t\t\t\nBEA28-90/I20-30,\t\t\t\t\t\t\t\t\nBEA28-70/I20-30,\t\t\t\t\t\t\t\t\nBEA28-50/I20-30,\t\t\t\t\t\t\t\t\nBEA28-110/I16-30,\t\t\t\t\t\t\t\t\nBEA28-90/I16-30,\t\t\t\t\t\t\t\t\nBEA28-70/I16-30,\t\t\t\t\t\t\t\t\nBEA28-50/I16-30,\t\t\t\t\t\t\t\t\nBEA28-100/I20-55,\t\t\t\t\t\t\t\t\nBEA28-80/I20-55,\t\t\t\t\t\t\t\t\nBEA28-100/I16-55,\t\t\t\t\t\t\t\t\nBEA28-80/I16-55",
      "code_info": "All lots distributed from 03/2011 to present.",
      "firm_fei_number": "3011063223",
      "recalling_firm": "Endologix",
      "address_1": "35 Hammond",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-1607",
      "reason_for_recall": "Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device.  This is a follow-up notification to the one that was sent out in December 2016.  The updates are related to the observation of Type III endoleaks.",
      "root_cause_description": "Device Design",
      "action": "On 07/31/2018, the firm mailed Urgent Important Safety Updates via FedEx ground service with return delivery confirmation. Physicians were informed about the following: 1) Type III endoleak rates, 2) Refined patient-tailored surveillance recommendations, 3) Sizing recommendations, 4) Recommendations for device interventions/ re-interventions. No product return is required. Customers with questions are encouraged to call Customer service 800-983-2284 (5:00 A.M. - 6:00 P.M. Pacific Time).\n\nUpdated 03/01/2023: \nBecause of the ongoing concerns regarding Type III endoleaks with Endologix AFX Endovascular AAA Graft Systems, the FDA has publicly communicated concerns:\n\nhttps://public4.pagefreezer.com/browse/FDA/21-08-2022T08:51/https:/www.fda.gov/medical-devices/letters-health-care-providers/update-type-iii-endoleaks-associated-endovascular-graft-systems-letter-health-care-providers\n\nUpdate on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication | FDA (pagefreezer.com)\n\nUPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication | FDA (pagefreezer.com)\n\nOn November 2, 2021, the FDA convened a public meeting of the CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee to share information and perspectives from interested parties on the benefit-risk profile of the Endologix AFX endovascular graft system focused on the risk of Type III endoleaks.",
      "product_quantity": "13178",
      "distribution_pattern": "U.S.:\nPA, VA, CA, AZ, IN, GA, FL, IL, OK, MN, OH, KY, MS, NC, MI, AL, CT, LA, SC, TN, NY, WI, MD, WV, AR, NV, NJ, TX, CO, NE, NM, MA, IA, AK, OR, ME, SD, MO, MT, KS, DE, WA, UT, NH, ND, DC, RI, HI, WY, ID, VT, PR;\n\nForeign (OUS):\nCanada, Argentina, Australia, Brazil, CHILE , Hong Kong, Japan, South Korea, Philippines, Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom",
      "openfda": {
        "pma_number": [
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          "P110038",
          "P110032",
          "P200045",
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        "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
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