{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "158760",
      "product_res_number": "Z-0032-2018",
      "event_date_initiated": "2017-08-28",
      "event_date_created": "2018-06-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-07-08",
      "res_event_number": "78093",
      "product_code": "NIK",
      "pma_numbers": [
        "P030054S135",
        "P030054S329"
      ],
      "product_description": "Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1\nThe Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.",
      "code_info": "Software version 23.1.1",
      "firm_fei_number": "2017865",
      "recalling_firm": "St Jude Medical Inc.",
      "address_1": "15900 Valley View Ct",
      "city": "Sylmar",
      "state": "CA",
      "postal_code": "91342-3577",
      "additional_info_contact": "Candace Steele Flippin\n651-756-6293",
      "reason_for_recall": "New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "Abbott sent an Important Cybersecurity Advisory dated August 28, 2017, to all affected customers to notify customers of the availability of the programmer software update and associated pacemaker firmware update. The notification material is in the form of a Physician Letter and Hospital Letter and will be delivered to physicians and hospitals with inventory in the US by overnight service. Customers with questions were instructed to contact their Abbott representative or the customers technical support hotline at 1-800-722-3774.",
      "product_quantity": "10,453 units",
      "distribution_pattern": "Worldwide Distribution",
      "openfda": {
        "pma_number": [
          "P000009",
          "P060027",
          "P880006",
          "P010012",
          "P970013",
          "P910023",
          "P050023",
          "P880086",
          "P030035",
          "P030054",
          "P010031"
        ],
        "registration_number": [
          "3008159616",
          "9610139",
          "2032521",
          "3005334138",
          "2017865",
          "3015453963",
          "3013500228",
          "3018094310",
          "3003120897",
          "3008494315",
          "1028232",
          "3009380063",
          "1000165971",
          "2133641",
          "3013288201",
          "3006705815",
          "2182208",
          "9616693",
          "2124215",
          "3005941719",
          "3013596024",
          "3033257494",
          "9614453",
          "2648729",
          "3012552532",
          "3002806603"
        ],
        "fei_number": [
          "3008159616",
          "3005334138",
          "2017865",
          "3015453963",
          "3013500228",
          "3018094310",
          "3003120897",
          "1028232",
          "3002807576",
          "3009380063",
          "3003574398",
          "1000165971",
          "3000203466",
          "3013288201",
          "3002807111",
          "3006705815",
          "2182208",
          "3002618605",
          "2124215",
          "3002806500",
          "3013596024",
          "3033257494",
          "3008377825",
          "2648729",
          "3012552532",
          "3002806603"
        ],
        "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}