{
  "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",
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      "product_res_number": "Z-0083-2014",
      "event_date_initiated": "2012-09-19",
      "event_date_posted": "2013-10-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-10-25",
      "res_event_number": "66322",
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      "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": "Jonathan Morris\n707-566-1143",
      "reason_for_recall": "Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.",
      "root_cause_description": "Component design/selection",
      "action": "A Medical Device Information letter was sent to all affected customers on September 19, 2012.  Additionally, all Medtronic Field Representatives were notified of the issue via a Field Memo",
      "product_quantity": "~1000",
      "distribution_pattern": "International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.",
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        "medical_specialty_description": "Unknown",
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