{
  "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": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82870",
      "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) to states of: UT, GA, NJ, CA, OH, PA, AL, FL, TN, TX, ME, MA, IN, MS, NY, VA, MI, IL, CO, OR, WA, SC, AZ, SD, MO, CT, OK, NV, WV, WI, NC, MN, KY; and countries of: United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic, Germany, France, United Kingdom, Italy, Netherlands, Poland, Romania, and Sweden.",
      "recall_number": "Z-1705-2019",
      "product_description": "IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4\" (100 cm), Rx Only, Sterile EO     The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.",
      "product_quantity": "6552",
      "reason_for_recall": "Possibility of balloon rupture in intra-aortic occlusion devices.  If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.",
      "recall_initiation_date": "20190514",
      "center_classification_date": "20190611",
      "termination_date": "20240423",
      "report_date": "20190619",
      "code_info": "All lot numbers."
    }
  ]
}