{
  "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": "49382",
      "product_res_number": "Z-0309-2007",
      "event_date_initiated": "2006-11-08",
      "event_date_posted": "2006-12-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-11-04",
      "res_event_number": "36803",
      "product_code": "MIH",
      "pma_numbers": [
        "P040042"
      ],
      "product_description": "Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL",
      "code_info": "Lot Numbers: W06-0333, W06-0392, W06-0500,  W06-0553, W06-0621, W06-1100 &  W06-1152",
      "firm_fei_number": "1000125107",
      "recalling_firm": "Endologix Inc",
      "address_1": "11 Studebaker",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-2013",
      "additional_info_contact": "Janet M. Fauls\n949-595-7203",
      "reason_for_recall": "Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.",
      "root_cause_description": "Other",
      "action": "The affected hospitals were contacted telephone on 11/08/06 and in writing (Recall Letters) sent via FedEx  11/09/06.  The firm also released a press statement on 11/10/06. All affected consignees have been contacted and instructed to return the specified products to Endologix.",
      "product_quantity": "11",
      "distribution_pattern": "Worldwide, including USA and Germany.",
      "openfda": {
        "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P110038",
          "P140016",
          "P070007",
          "P180001",
          "P040002",
          "P040043",
          "P120006",
          "P110032",
          "P020018",
          "P100021",
          "P100040",
          "P200030",
          "P150002",
          "P990020",
          "P990017",
          "P210032",
          "P190015",
          "P070027",
          "P020004",
          "P200045",
          "P070016"
        ],
        "registration_number": [
          "1820334",
          "3004497303",
          "3008307705",
          "3005580113",
          "2030624",
          "9616099",
          "2247858",
          "3011063223",
          "3007738736",
          "3002807314",
          "3013164176",
          "3006131984",
          "2017233",
          "3009380063",
          "3002808486",
          "9710641",
          "3007284313",
          "3016521833",
          "9612164",
          "3008011247",
          "9680654",
          "3011324393",
          "2011171",
          "3012102437",
          "3009526575",
          "1721686",
          "9680271",
          "1054811",
          "3005562917",
          "1219313",
          "3003678543",
          "1721676",
          "9617601",
          "2953200"
        ],
        "fei_number": [
          "1820334",
          "3004497303",
          "3002534070",
          "3002806434",
          "3008307705",
          "3005580113",
          "3003565456",
          "3007530363",
          "3003259710",
          "3007738736",
          "3002807314",
          "3011063223",
          "3013164176",
          "3006131984",
          "2017233",
          "3009380063",
          "3002808486",
          "3007284313",
          "3016521833",
          "3008011247",
          "1000114185",
          "3011324393",
          "2011171",
          "1000135961",
          "3012102437",
          "3003528016",
          "3009526575",
          "3001452571",
          "1721686",
          "3000206435",
          "3005562917",
          "1219313",
          "3003678543",
          "1721676"
        ]
      }
    }
  ]
}