{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "179519",
      "product_res_number": "Z-1449-2020",
      "event_date_initiated": "2020-01-14",
      "event_date_posted": "2020-02-14",
      "recall_status": "Open, Classified",
      "res_event_number": "84837",
      "product_code": "DTI",
      "product_description": "Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.",
      "code_info": "GTIN: 00643169707535",
      "firm_fei_number": "2025587",
      "recalling_firm": "Medtronic CoreValve LLC",
      "address_1": "1851 E Deere Ave",
      "city": "Santa Ana",
      "state": "CA",
      "postal_code": "92705-5720",
      "additional_info_contact": "Rick Leonard\n763-514-9609",
      "reason_for_recall": "Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers.  The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm initiated the recall by email or verbal contact on 01/14/2020.  The direct consignees (sales representatives) were directed to quarantine and return the affected product.\n\nOn 02/05/2020, consignees (hospitals) were notified by letter delivered by the Medtronic Sales Representatives.  The notices directed the consignee  to not use the affected product for clinical use, quarantine and return affected product.  Affected product will be replaced by Medtronic.",
      "product_quantity": "6",
      "distribution_pattern": "US Nationwide distribution in the states of Ohio and Kansas.",
      "openfda": {
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        "device_name": "Sizer, Heart-Valve, Prosthesis",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3945",
        "device_class": "1"
      }
    }
  ]
}