{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "186850",
      "product_res_number": "Z-1591-2021",
      "event_date_initiated": "2021-04-12",
      "event_date_created": "2021-05-19",
      "recall_status": "Open, Classified",
      "res_event_number": "87721",
      "product_code": "QAN",
      "pma_numbers": [
        "P180013"
      ],
      "product_description": "VICI VENOUS STENT System\n\nProduct Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.",
      "code_info": "all batches/lots of the device manufactured between May 2018 through April 2021",
      "firm_fei_number": "3002095335",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "city": "Maple Grove",
      "state": "MN",
      "postal_code": "55311-1565",
      "additional_info_contact": "Rebecca KinKead Rubio\n763-494-1700",
      "reason_for_recall": "The firm has received reports of stent migration after implantation",
      "root_cause_description": "Under Investigation by firm",
      "action": "Boston Scientific initiated the recall by letter on April 12, 2021.  The letter requested the consignee cease use and further distribution of the affected product, segregate and return to Boston Scientific.  Distributors were directed to further distribute the notice to their customers.  For questions contact your local Sales Representative.",
      "product_quantity": "550 units",
      "distribution_pattern": "Worldwide - US Nationwide Distribution",
      "openfda": {
        "pma_number": [
          "P180037",
          "P230021",
          "P200026",
          "P200023",
          "P980033",
          "P180013"
        ],
        "registration_number": [
          "3002807090",
          "3005580113",
          "2020394",
          "3009526575",
          "3005111382",
          "9681442",
          "3005941719",
          "2183870",
          "3009380063",
          "1000121056",
          "2183744",
          "9681260",
          "3001845648",
          "3002807314",
          "3002504068",
          "3016257349",
          "2124215"
        ],
        "fei_number": [
          "3005580113",
          "3002806368",
          "3002807111",
          "2020394",
          "3009526575",
          "3005111382",
          "3002806565",
          "2183870",
          "3009380063",
          "3006003617",
          "1000121056",
          "2183744",
          "3001845648",
          "3002807314",
          "3002504068",
          "3016257349",
          "2124215"
        ],
        "device_name": "Stent, Iliac Vein",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}