{
  "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": "Saint Paul",
      "address_1": "4100 Hamline Ave N",
      "reason_for_recall": "Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted.  This alternate configuration did not receive FDA approval yet.",
      "address_2": "",
      "product_quantity": "5",
      "code_info": "serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.",
      "center_classification_date": "20160907",
      "distribution_pattern": "Distributed to the states of TX, NH, MA, PA, and MN.",
      "state": "MN",
      "product_description": "Pacemakers:  Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111.      These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.",
      "report_date": "20160914",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Boston Scientific Corporation",
      "recall_number": "Z-2749-2016",
      "initial_firm_notification": "Visit",
      "product_type": "Devices",
      "event_id": "74812",
      "termination_date": "20170206",
      "more_code_info": "",
      "recall_initiation_date": "20160615",
      "postal_code": "55112-5700",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}