{
  "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": "Draper",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65744",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "12050 Lone Peak Pkwy",
      "address_2": "",
      "postal_code": "84020-9414",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide including Canada and VA sites.",
      "recall_number": "Z-1972-2013",
      "product_description": "Edwards EndoReturn Arterial Cannula, model ER21B and ER23B    Product Usage:  The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility, tapered tips to aid in insertion and advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in. (9.5 mm) barbed connector, and a hemostasis valve (available on some versions) that allows passage of catheters, such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions, a connector hub secures and immobilizes the introducer within the cannula for easier, one person insertion of the cannula/introducer assembly.",
      "product_quantity": "855",
      "reason_for_recall": "Edwards Lifesciences is recalling certain lots of the  EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a  performance problem with the IntraClude IntraAortic Occlusion device.",
      "recall_initiation_date": "20130716",
      "center_classification_date": "20130814",
      "termination_date": "20161130",
      "report_date": "20130821",
      "code_info": "Model ER21B Lots: 59496984, 59516933, 59516936, 59531385, 59531386 , 59543708     Model ER23B Lots: 59464327, 59484349, 59484350, 59484351, 59512146, 59513272, 59516940, 59534430, 59535739, 59541763",
      "more_code_info": ""
    }
  ]
}