{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mounds View",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78888",
      "recalling_firm": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)",
      "address_1": "8200 Coral Sea St Ne",
      "address_2": "N/A",
      "postal_code": "55112-4391",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Other",
      "distribution_pattern": "US Nationwide Distribution.",
      "recall_number": "Z-0584-2018",
      "product_description": "Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva.  Labeled as the following:    a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ);    b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ);    c. Viva S CRT-D DF1 (Product No. DTBB1D1);    d. Viva XT CRT-D DF1 (Product No. DTBA1D1);    e. Viva XT CRT-D DF4 (Product No. DTBA1D4);      EXPANSION:    f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1);    g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1);    h. Viva S CRT-D DF4 (Product No. DTBB1D4)    Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).",
      "product_quantity": "951 devices total",
      "reason_for_recall": "Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).",
      "recall_initiation_date": "20171219",
      "center_classification_date": "20180419",
      "termination_date": "20210827",
      "report_date": "20180228",
      "code_info": "a. Product No. DTBB1QQ: UDI 00643169530218 (Serial No. BLK204122H) (EXPANSION: Serial No. BLK202087H, BLK203257H, BLK204050H, BLK204435H);    b. Product No. DTBA1QQ: UDI 00643169007222 (Serial No. BLC224272H) (EXPANSION: Serial No. BLC200490H, BLC205825H, BLC205826H, BLC205827H, BLC206202H, BLC206263H, BLC208305H, BLC208471H, BLC211869H, BLC215219H, BLC215544H, BLC218906H, BLC219515H, BLC220190H, BLC221044H, BLC221045H, BLC221046H, BLC221047H, BLC222903H, BLC223278H, BLC223517H, BLC224374H, BLC224553H, BLC224554H, BLC224555H, BLC224556H, BLC224655H, BLC225498H, BLC225502H, BLC225682H, BLC225734H, BLC226030H, BLC226031H, BLC226032H, BLC226033H, BLC226034H, BLC226035H, BLC226040H, BLC227270H, BLC227659H, BLC227662H, BLC205767H, BLC205828H, BLC211870H, BLC226988H, BLC227212H, BLC227728H, BLC227740H), 00643169530171 (Serial No. BLC227175H, BLC227641H);    c. Product No. DTBB1D1: UDI 00643169007185 (Serial No. BLO204984H) EXPANSION: Serial No. BLO210650H, BLO212502H, BLO201695H, BLO204429H, BLO206930H, BLO207702H, BLO208974H, BLO210408H, BLO210409H, BLO210770H, BLO212131H, BLO212481H, BLO212491H, BLO212493H, BLO212503H, BLO212504H, BLO212505H, BLO212506H, BLO212507H, BLO212729H, BLO213454H, BLO213467H, BLO213468H, BLO213592H, BLO213780H, BLO213781H, BLO201347H, BLO201436H, BLO208063H, BLO212501H, BLO213783H, BLO213784H, BLO213786H);    d. Product No. DTBA1D1: UDI 00643169530140 (Serial No. BLF253790H, BLF254092H, BLF250740H, BLF251155H), 00643169007246 (Serial No. BLF216780H, BLF231229H) (EXPANSION: Serial No. BLF243217H, BLF247858H, BLF202387H, BLF202535H, BLF204112H, BLF205853H, BLF206730H, BLF206788H, BLF207518H, BLF207678H, BLF210779H, BLF210782H, BLF211003H, BLF211357H, BLF211358H, BLF213450H, BLF213658H, BLF218473H, BLF219583H, BLF219667H, BLF221248H, BLF222061H, BLF224098H, BLF224106H, BLF224214H, BLF224230H, BLF224242H, BLF224253H, BLF224260H, BLF224386H, BLF224483H, BLF227680H, BLF227903H, BLF227947H, BLF228849H, BLF230968H, BLF232235H, BLF232254H, BLF234692H, BLF235138H, BLF237753H, BLF238241H, BLF238700H, BLF239221H, BLF239916H, BLF243268H, BLF243674H, BLF245571H, BLF245572H, BLF245893H, BLF246563H, BLF247381H, BLF247435H, BLF247466H, BLF248396H, BLF248398H, BLF248399H, BLF248400H, BLF248401H, BLF248402H, BLF248403H, BLF248464H, BLF249952H, BLF250022H, BLF250142H, BLF250143H, BLF250389H, BLF250392H, BLF250393H, BLF250751H, BLF251380H, BLF253085H, BLF253406H, BLF253407H, BLF253618H, BLF253795H, BLF253796H, BLF253798H, BLF253801H, BLF253802H, BLF253803H, BLF253806H, BLF253820H, BLF253853H, BLF254774H, BLF254776H, BLF254777H, BLF254778H, BLF254779H, BLF200834H, BLF205341H, BLF218472H, BLF218474H, BLF220892H, BLF224264H, BLF250752H, BLF205821H, BLF210550H, BLF222642H, BLF251852H, BLF253755H, BLF253852H, BLF253797H, BLF253799H), 00643169929296 (Serial No. BLF255165H, BLF255598H;    e. Product No. DTBA1D4: UDI 00643169530157 (Serial No. BLE219903H), 00643169929302 (Serial No. BLE220200H), EXPANSION: UDI 00643169007239 (Serial No. BLE205339H, BLE203253H, BLE203582H, BLE203583H, BLE204049H, BLE205304H, BLE209377H, BLE209554H, BLE212368H, BLE213926H, BLE218673H, BLE218892H, BLE218902H, BLE219909H, BLE219911H, BLE219914H, BLE208468H, BLE204048H, BLE214123H, BLE217805H, BLE219910H, BLE220390H, BLE219912H);      EXPANSION:    f. Product No. DTBB1Q1: UDI 00643169017993 (Serial No. BLM201868H, BLM202644H, BLM202773H, BLM202775H);    g. Product No. DTBA1Q1: UDI 00643169018013 (Serial No, BLD202507H, BLD202778H, BLD203541H, BLD207024H, BLD208443H, BLD209856H, BLD210102H, BLD210103H, BLD210175H, BLD210220H, BLD210223H, BLD210251H, BLD210257H, BLD210258H, BLD210259H, BLD210260H, BLD211370H, BLD211371H, BLD211681H, BLD211682H, BLD202666H, BLD210700H, BLD210738H, BLD211680H, BLD210699H);    h. Product No. DTBB1D4: UDI 00643169007178 (Serial No. BLN201692H, BLN201722H, BLN202203H, BLN202897H, BLN204159H, BLN202355H)"
    }
  ]
}