{
  "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": [
    {
      "country": "United States",
      "city": "Santa Ana",
      "address_1": "1851 E Deere Ave",
      "reason_for_recall": "Due to reports of actuator separation for various delivery catheter systems.  Affected products were manufactured before July 11, 2020.",
      "address_2": "",
      "product_quantity": "Total of all Delivery Systems (Globally) = 67,339 units",
      "code_info": "Model Number/Description: D-EVPROP2329US/DELIV SYS D-EVPROP2329US  GTIN:00763000207854  Lot Numbers:  0010165308;  0010165310;  0010165312;  0010165313;  0010169462;  0010169464;  0010171866;  0010171868;  0010171869;  0010173361;  0010175293;  0010175294;  0010181410;  0010181411;  0010181412;  0010182735;  0010182736;  0010188541;  0010192246;  0010192247;  0010197788;  0010197790;  0010199877;  0010199878;  0010199880;  0010204029;  0010216175;  0010216176;  0010222009;  0010222011;  0010225047;  0010271291;  0010271292;  0010271293;  0010273071;  0010279050;  0010279938;  0010288574;  0010289862;  0010291595;  0010291597;  0010294650;  0010294651;  0010294652;  0010296300;  0010296301;    Model Number/Description:D-EVPROP34US/DELIV SYS D-EVPROP34US SA  GTIN:00763000207861  Lot Numbers:  0010165309;  0010165311;  0010291593;  0010294653;  0010294654;  0010303395;",
      "center_classification_date": "20210708",
      "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.    O.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.",
      "state": "CA",
      "product_description": "CoreValve Evolut PRO PLUS Delivery Catheter System,  REF:  D-EVPROP2329US;  D-EVPROP34US;",
      "report_date": "20210714",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic Heart Valves Division",
      "recall_number": "Z-2043-2021",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "88113",
      "more_code_info": "",
      "recall_initiation_date": "20210611",
      "postal_code": "92705-5720",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}