{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "187914",
      "product_res_number": "Z-2041-2021",
      "event_date_initiated": "2021-06-11",
      "event_date_created": "2021-07-09",
      "recall_status": "Open, Classified",
      "res_event_number": "88113",
      "product_code": "NPT",
      "product_description": "CoreValve Evolut R Delivery Catheter System,\nREF:\nENVEOR-L;\nENVEOR-N;",
      "code_info": "Model Number/Description: ENVEOR-L/DELIV SYS EnVeoR-L OREVAC 18Fr GTIN: 00643169800922 Lot Numbers: 0010199879; 0010204030; 0010209069; 0010209070; 0010279048; 0010281657; 0010289860; 0010296299;  Model Number/Description: ENVEOR-N/DELIV SYS EnVeoR-N OREVAC 20Fr GTIN: 00643169800946 Lot Numbers 0010199873; 0010199874; 0010209064; 0010211942; 0010253924; 0010258778; 0010260161; 0010262936; 0010289861; 0010296302; 0010297110; 0010301887;",
      "firm_fei_number": "2025587",
      "recalling_firm": "Medtronic Heart Valves Division",
      "address_1": "1851 E Deere Ave",
      "city": "Santa Ana",
      "state": "CA",
      "postal_code": "92705-5720",
      "additional_info_contact": "888-2837868",
      "reason_for_recall": "Due to reports of actuator separation for various delivery catheter systems.  Affected products were manufactured before July 11, 2020.",
      "root_cause_description": "Device Design",
      "action": "On 06/09/2021, the Recalling Firm sent an \"URGENT MEDICAL DEVICE RECALL\" Notification via UPS 2-day (US Customers) and  regionally approved methods (OUS Customer) to customers informing  them that it has been identified that were is the potential for actuator separation with delivery catheter systems manufactured before 07/11/2020.\n\nCustomer are instructed to:\n1. Identify and quarantine all unused affected product manufactured before 11-JUL-2020.The enclosed Customer Notification Detail Report includes affected product for their facility.\n2. Return all unused affected product in their inventory to Recalling Firm. Contact  Customer Service at 800-854-3570 to initiate a product return. Their local Representative can assist them as necessary in initiating the return of this product.\n3. Complete the enclosed Customer Confirmation Form and email it to rs.cfqfca@medtronic.com.\n4. Forward this notice to all who need to be aware within their organization and to any organization where the affected product may have been transferred.\n\nFor any questions or assistance, contact Customer Service at 800-854-3570",
      "product_quantity": "Total of all Delivery Systems (Globally) = 67,339 units",
      "distribution_pattern": "U.S.: AL, AK, AR, AZ, CA, CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.\n\nO.U.S.: Albania, Argentina, Australia, Austria, Belarus, Belgium, Brazil, BULGARIA, Canada, Chile, CHINA, Colombia, COSTA RICA, Croatia, Curacao, CYPRUS, Czech Republic, Denmark, DOMINICAN REPUBLIC, Egypt, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, Germany, Greece, GUATEMALA, HONDURAS, Hong Kong, Hungary, ICELAND, India, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), Ireland, Israel, Italy, Japan, JORDAN, KAZAKHSTAN, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LITHUANIA, Luxembourg, MACEDONIA (THE FORMER YUGOSLAV REPUBLIC OF), Malaysia, MALTA, Mexico, MOLDOVA (REPUBLIC OF), Montenegro, Netherlands, New Zealand, Norway, OMAN, Panama, Peru, Poland, Portugal, QATAR, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, SLOVAKIA (Slovak Republic), SLOVENIA, South Africa, Spain, Sweden, Switzerland, SYRIAN ARAB REPUBLIC, Taiwan (Republic of China), THAILAND, Turkey, UNITED ARAB EMIRATES, United Kingdom, URUGUAY, UZBEKISTAN, VENEZUELA and Viet Nam.",
      "openfda": {
        "pma_number": [
          "P250024",
          "P180029",
          "P130021",
          "P140031",
          "P110021",
          "P100041",
          "P130009",
          "P190023"
        ],
        "device_name": "Aortic Valve, Prosthesis, Percutaneously Delivered",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3007063218",
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        "fei_number": [
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      }
    }
  ]
}