{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mounds View",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97125",
      "recalling_firm": "Medtronic, Inc.",
      "address_1": "8200 Coral Sea St Ne",
      "address_2": "N/A",
      "postal_code": "55112-4391",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide",
      "recall_number": "Z-2128-2025",
      "product_description": "Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components:    1.\tAzure Astra application, Software Model Number D00U003;    2.\tPercepta Serena Solara application, Software Model Number D00U004;    3.\tCobalt Crome application, Software Model Number D00U005;    4.\tMicra VR application, Software Model Number D00U006;    5.\tMicra AV application, Software Model Number D00U007;    6.\tViva Consulta Syncra Advisa Ensura application, Software Model Number D00U008;    7.\tClaria Amplia Compia application, Software Model Number D00U009;    8.\tEvera MRI application, Software Model Number D00U010;    9.\tVisia AF application, Software Model Number D00U011;    10.\tViva Brava Evera application, Software Model Number D00U012;    11.\tMicra VR2 AV2 application, Software Model Number D00U022.",
      "product_quantity": "5418 units",
      "reason_for_recall": "A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available.  The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.",
      "recall_initiation_date": "20250617",
      "center_classification_date": "20250717",
      "report_date": "20250723",
      "code_info": "1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5;  2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5;  3. Software Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2;  4. Software Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6;  5. Software Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6;  6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5;  7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2;  8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2; 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2; 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2; 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5."
    }
  ]
}