{
  "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": [
    {
      "country": "United States",
      "city": "Irvine",
      "address_1": "9775 Toledo Way",
      "reason_for_recall": "Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication:  Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location.  Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication \"",
      "address_2": "",
      "product_quantity": "62 units",
      "code_info": "Model/Lot Numbers:    FA-71400-25 / 9747602   FA-77350-18 / 9749412   FA-77400-20 / 9759088  FA-71500-35 / 9747604   FA-77375-16 / 9744487   FA-77425-16 / 9752788  FA-77300-16 / 9757068   FA-77375-20 / 9757065   FA-77425-20 / 9744123  FA-77325-14 / 9759141   FA-77400-14 / 9757233   FA-77425-20 / 9752438  FA-77325-16 / 9753034   FA-77400-14 / 9768698   FA-77450-18 / 9753033  FA-77325-16 / 9757024   FA-77400-16 / 9743468   FA-77475-20 / 9752787  FA-77325-18 / 9759560   FA-77400-18 / 9751579   FA-77500-20 / 9750678  FA-77350-16 / 9752785   FA-77400-20 / 9755707",
      "center_classification_date": "20130823",
      "distribution_pattern": "US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.",
      "state": "CA",
      "product_description": "Pipeline Embolization Device (PED)    The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.",
      "report_date": "20130904",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Micro Therapeutics Inc, Dba Ev3 Neurovascular",
      "recall_number": "Z-2045-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "65810",
      "termination_date": "20131017",
      "more_code_info": "",
      "recall_initiation_date": "20130719",
      "postal_code": "92618-1811",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}