{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217744",
      "product_res_number": "Z-1098-2026",
      "event_date_initiated": "2025-12-04",
      "event_date_posted": "2026-01-15",
      "recall_status": "Open, Classified",
      "res_event_number": "98157",
      "product_code": "QAN",
      "pma_numbers": [
        "P200026"
      ],
      "product_description": "Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090\nAB9G12100090\nAB9G14080090\nAB9G12080090\nAB9U12060090\nAB9U14100090\nAB9U14080090\nAB9U12080090\nAB9U14060090\nAB9G14100090\nAB9G12060090",
      "code_info": "UDI-DI (GTIN):\n\n00763000547332\n00763000547271\n00763000547318\n00763000547264\n00643169796225\n00643169796300\n00643169796294\n00643169796232\n00643169796287\n00763000547325\n00643169796300\n00763000547257\n\nSerial/Lot numbers\n\nC112511\nC113253\nC113795\nC117416\nC117482\nC121084\nC123953\nC133327\nC133329\nC134478\nC138060\nC150325",
      "firm_fei_number": "2183870",
      "recalling_firm": "Medtronic Inc",
      "address_1": "4600 Nathan Ln N",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55442-2890",
      "additional_info_contact": "PVH Customer Service\n800-716-6700",
      "reason_for_recall": "Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Beginning 04-Dec-2025, Medtronic distributed an Urgent Medical Device Recall notice to all U.S. consignees who have impacted products via mail courier.\n\nConsignees were instructed to complete and return a response form to the firm and to return any affected product they may have.",
      "product_quantity": "442",
      "distribution_pattern": "Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, \nLebanon, Malaysia, Netherlands, New Zealand, Peru, Poland, Russia, Singapore, Spain, \nSwitzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam.",
      "openfda": {
        "pma_number": [
          "P230021",
          "P180037",
          "P980033",
          "P200026",
          "P180013",
          "P200023"
        ],
        "registration_number": [
          "3009526575",
          "3002807314",
          "3016257349",
          "9681260",
          "3009380063",
          "3005111382",
          "2183870",
          "3005941719",
          "3002504068",
          "9681442",
          "3001845648",
          "2124215",
          "2020394",
          "2183744",
          "1000121056",
          "3002807090",
          "3005580113"
        ],
        "fei_number": [
          "3009526575",
          "3002807314",
          "3016257349",
          "2020394",
          "3009380063",
          "3005111382",
          "2183870",
          "3002807111",
          "3002504068",
          "3001845648",
          "3002806565",
          "2124215",
          "3002806368",
          "2183744",
          "1000121056",
          "3006003617",
          "3005580113"
        ],
        "device_name": "Stent, Iliac Vein",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}