{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98615",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N",
      "address_2": "",
      "postal_code": "55112-5700",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "worldwide",
      "recall_number": "Z-1771-2026",
      "product_description": "Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as:    1. VALITUDE CRT-P EL, Model Number U125;   2. VALITUDE CRT-P EL MRI, Model Number U128;   3. VISIONIST CRT-P EL, Model Number U225;   4. VISIONIST CRT-P EL, Model Number U226;   5. VISIONIST CRT-P EL MRI, Model Number U228.",
      "product_quantity": "685,776 units",
      "reason_for_recall": "Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE\" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices.    Dual chamber modes are specifically indicated for treatment of the following:    \" Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block    \" VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm    \" Low cardiac output or congestive heart failure secondary to bradycardia",
      "recall_initiation_date": "20260319",
      "center_classification_date": "20260424",
      "report_date": "20260506",
      "code_info": "The advisory population includes all models listed; however, the bounding differs by battery type:   \"  All serialized DR-EL pacemakers and CRT-Ps from the ACCOLADE family are included in the advisory population.   \"  ACCOLADE DR-SL and SR-SLs with a use-by-date (UBD) on or before 30 June 2025 are included in the advisory population. Model number alone will not precisely identify individual DR-SL or SR-SL devices in the advisory population.   To determine if a device is affected, enter a model/serial into the device lookup tool at www.BostonScientific.com/lookup.",
      "more_code_info": ""
    }
  ]
}