{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Los Gatos",
      "address_1": "160 Knowles Dr",
      "reason_for_recall": "Lotus valve became unlocked during release from the delivery system.  This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.",
      "address_2": "",
      "product_quantity": "278 units - total all sizes",
      "code_info": "Serial numbers:  14126051, 14126052, 14126053, 14127058, 14128047, 14128048, 14128049, 14128050, 14129004, 14129005, 14129006, 14129007,  14129008, 14133006, 14133007, 14133008, 14133009, 14133010, 14134042, 14134043, 14134044, 14134045, 14134047, 14134049,  14134050, 14134054, 14148005, 14148006, 14148007, 14148008, 14148009, 14148010, 14148011, 14148012, 14148013, 14148014,  14148015, 14148019, 14148020, 14148021, 14148022, 14148023, 14148024, 14148026, 14148027, 14156025, 14156026, 14157007,  14157008, 14157009, 14157010, 14157011, 14157012, 14157013, 14160009, 14160011, 14160012, 14160015, 14161036, 14161037,  14161038, 14161040, 14162050, 14162051, 14162053, 14162054, 14163052, 14163053, 14163054, 14163055, 14165004, 14165005,  14165006, 14165007, 14165008, 14167012, 14167013, 14167015, 14167016, 14167017, 14167018, 14167019, 14167020, 14167021,  14170001, 14170002, 14170003, 14170004, 14170005, 14170031, 14170032, 14170034, 14170035, 14170036, 14170037, 14170038,  14170039, 14170040, 14171031, 14171032, 14171033, 14171036, 14171037, 14171038, 14171039, 14171040, 14172017, 14172018,  14172019, 14172020, 14172021, 14172022, 14172023, 14172024, 14176021, 14176022, 14176023, 14176024, 14176025, 14176029,  14176030, 14176031, 14176032, 14176033, 14178036, 14178038, 14178039, 14178040, 14178041, 14178042, 14178043, 14178045,  14179048, 14179050, 14179051, 14179052, 14179053, 14179054, 14179055, 14179057, 14182027, 14182029, 14182031, 14183011,  14183013, 14183014, 14183015, 14184003, 14184004, 14184005, 14184006, 14184007, 14184008, 14184009, 14184010, 14184011,  14188009, 14188010, 14188012, 14188013, 14188014, 14188015, 14188016, 14188017, 14188018, 14191021, 14191022, 14191023,  14191024, 14191030, 14193002, 14193003, 14193007, 14193011, 14193012, 14193013, 14193014, 14193022, 14197042, 14197047,  14197048, 14197049.  Expiry Datres Nov. 15, 2014 to Jan. 24, 2015.",
      "center_classification_date": "20150113",
      "distribution_pattern": "Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.",
      "state": "CA",
      "product_description": "Lotus TAVR 25mm,   Transcatheter Aortic Valve Prosthesis Premounted on Delivery System;  Sterile  Material number H749LTV250, Catalog Number LTV25;  Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2  or AVA index of <0.6 em /m2)  who are at extreme or high risk for standard surgical valve replacement.",
      "report_date": "20150121",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Boston Scientific Corporation",
      "recall_number": "Z-0916-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "69931",
      "termination_date": "20150326",
      "more_code_info": "",
      "recall_initiation_date": "20141119",
      "postal_code": "95032-1828",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}