{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81928",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "1 Edwards Way",
      "address_2": "N/A",
      "postal_code": "92614-5688",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, France Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, UAE, and United Kingdom.",
      "recall_number": "Z-1100-2019",
      "product_description": "Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device     is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation.  The balloon expands to occlude a range of aorta sizes from 20 to 40 mm.      The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root.  The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring.",
      "product_quantity": "2715 units",
      "reason_for_recall": "Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.",
      "recall_initiation_date": "20190116",
      "center_classification_date": "20190405",
      "report_date": "20190417",
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    }
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}