{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "214626",
      "product_res_number": "Z-2168-2025",
      "event_date_initiated": "2025-06-18",
      "event_date_posted": "2025-07-23",
      "recall_status": "Open, Classified",
      "res_event_number": "97130",
      "product_code": "NVZ",
      "pma_numbers": [
        "P890003"
      ],
      "product_description": "Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components:  \r\n1.\tCobalt Crome application, Software Model Number D00U005;  \r\n2.\tClaria Amplia Compia application, Software Model Number D00U009;  \r\n3.\tEvera MRI application, Software Model Number D00U010;  \r\n3.\tVisia AF application, Software Model Number D00U011;  \r\n5.\tViva Brava Evera application, Software Model Number D00U012;",
      "code_info": "1.\tSoftware Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; \n2.\tSoftware Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; \n3.\tSoftware Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2; \n4.\tSoftware Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6; \n5.\tSoftware Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6; \n6.\tSoftware Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; \n7.\tSoftware Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; \n8.\tSoftware Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2;\n9.\tSoftware Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2;\n10.\tSoftware Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2;\n11.\tSoftware Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.",
      "firm_fei_number": "2182208",
      "recalling_firm": "Medtronic, Inc.",
      "address_1": "8200 Coral Sea St Ne",
      "city": "Mounds View",
      "state": "MN",
      "postal_code": "55112-4391",
      "additional_info_contact": "Technical Services\n800-929-4043",
      "reason_for_recall": "In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.",
      "root_cause_description": "Software design",
      "action": "An URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letter dated 6/18/25 was sent to customers.\n\nCustomer Actions:\n\"Update SmartSync (to version 4.2.3 or higher). Refer to release notes provided by your local Medtronicrepresentative for update instructions. If needed, Medtronic representatives are available to work with you toinstall or update the SmartSync application(s) on your tablet. See Appendix for instructions on how to verify thesoftware update is complete.\n\"Sign and return the enclosed confirmation form and share this notice with those who need to be aware withinyour organization or with any organization where SmartSync may be in use. Questions regarding this informationshould be directed to the local Medtronic Representative or Medtronic Programmer Technical Services at 800-638-1991, Option 1.",
      "product_quantity": "22091 total devices",
      "distribution_pattern": "Worldwide - US Nationwide distribution.",
      "openfda": {
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          "P880038",
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        "fei_number": [
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        "device_name": "Pulse Generator, Permanent, Implantable",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}