{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Mounds View",
      "address_1": "8200 Coral Sea St NE",
      "reason_for_recall": "78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.",
      "address_2": "",
      "product_quantity": "78 (39 US, 39 OUS)",
      "code_info": "Product Name:  Viva XT CRT -D .  Models:  DTBA1D4, DTBA1D1.  Serial Numbers:   BLF203128H, BLF204746H, BLE202888H, BLE202889H, BLE202890H, BLE202901H, BLE202941H, BLE202947H, BLE202954H, BLE202958H, BLE202961H, BLE202962H, BLE202964H, BLE202981H, BLE202987H, BLE202989H, BLE202990H, BLE202991H, BLE203019H, BLE203026H, BLE203027H, BLE203029H, BLE203032H, BLE203046H, BLE203052H, BLE203073H    Product Name: Viva S CRT-D.  Models:  DTBB1D4, DTBB1D1.  Serial Numbers: BLO202272H, BLN202206H.",
      "center_classification_date": "20160824",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom.",
      "state": "MN",
      "product_description": "Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators:  Product                 Model  VIVAXTCRT-D     DTBA1D1, DTBA1D4  VIVASCRT-D       DTBB1D1, DTBB1D4    Product Usage:  The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patient\u0019s heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies.",
      "report_date": "20160831",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic Inc., Cardiac Rhythm and Heart Failure",
      "recall_number": "Z-2650-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74923",
      "termination_date": "20170120",
      "more_code_info": "",
      "recall_initiation_date": "20160812",
      "postal_code": "55112-4391",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}