{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Santa Rosa",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67646",
      "recalling_firm": "Medtronic Vascular, Inc.",
      "address_1": "3576 Unocal Pl",
      "address_2": "N/A",
      "postal_code": "95403-1774",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US including the states of  IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.",
      "recall_number": "Z-1304-2014",
      "product_description": "FIBERNET Embolic Protection System:  Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter:  0.014 in (0.36mm)  Rx only, Sterile;  Manufactured in:  Invatec S.P.A., Italy;  Manufacturer:  Medtronic Inc.  Minneapolis, MN.    The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.",
      "product_quantity": "50 Total all sizes: 18 in US, 32 Internationally.",
      "reason_for_recall": "Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.",
      "recall_initiation_date": "20140303",
      "center_classification_date": "20140327",
      "termination_date": "20140603",
      "report_date": "20140402",
      "code_info": "US Model Number FBC 500600190, lot number 1E029176;  International Model Number FBN500600190, lot number 1E012914."
    }
  ]
}