{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "186464",
      "product_res_number": "Z-1522-2021",
      "event_date_initiated": "2021-04-06",
      "event_date_created": "2021-04-30",
      "recall_status": "Open, Classified",
      "res_event_number": "87654",
      "product_code": "OSR",
      "pma_numbers": [
        "P890003S386"
      ],
      "product_description": "CareLink SmartSync Device Manager (24970A).  used to interrogate cardiac implantable electronic devices (CIED).",
      "code_info": "All serial numbers",
      "firm_fei_number": "2182208",
      "recalling_firm": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)",
      "address_1": "8200 Coral Sea St Ne",
      "city": "Mounds View",
      "state": "MN",
      "postal_code": "55112-4391",
      "additional_info_contact": "Technical Services\n763-505-6000",
      "reason_for_recall": "There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).",
      "root_cause_description": "Software design",
      "action": "Beginning 06-APR-2021, Medtronic notified risk managers and practice managers of the field corrective action notification via 2-day UPS delivery of the consignee letter.\nConfirmation delivery of the consignee letter will be obtained. Medtronic Field Representatives have been instructed to begin installation of the software update.\nOutside the United States (OUS), communication began on 06- APR-2021 using locally approved methods. Medtronic Field Representatives will begin installation of the software update as it is available locally.\nConsignees were advised that Medtronic representatives can assist in installing the software update on programmers. During device interrogation with an updated programmer at implant or the next regularly scheduled clinic visit, a patients device will automatically receive the updated software.\nA courtesy notification will be provided to physicians. No confirmation will be required for the courtesy notification.",
      "product_quantity": "16,311 devices",
      "distribution_pattern": "Worldwide",
      "openfda": {
        "pma_number": [
          "P950037",
          "P150033",
          "P830060",
          "P980049",
          "P010012",
          "P050023",
          "P150035",
          "P010031",
          "P910077",
          "P890003"
        ],
        "registration_number": [
          "3013500228",
          "3002807314",
          "3012552532",
          "3008494315",
          "3013288201",
          "2032521",
          "3018094310",
          "9612164",
          "2135338",
          "1028232",
          "3013596024",
          "3008483389",
          "2183787",
          "3003120897",
          "3005210579",
          "2133641",
          "2648729",
          "9610139",
          "1000165971",
          "3015453963",
          "2124215",
          "9614453",
          "2649622",
          "3006705815",
          "9616693",
          "3033257494",
          "2017865",
          "3013921506",
          "3009380063",
          "3010972758",
          "3008159616",
          "2182208",
          "3011120183",
          "3002806603",
          "3004593495"
        ],
        "fei_number": [
          "3002618605",
          "3013500228",
          "3002807314",
          "3012552532",
          "3005700659",
          "3013288201",
          "3002806500",
          "3018094310",
          "3002806434",
          "3003574398",
          "1028232",
          "3013596024",
          "3000203466",
          "3008483389",
          "2183787",
          "3003120897",
          "3005210579",
          "2648729",
          "1000165971",
          "3002807576",
          "3015453963",
          "3008377825",
          "2124215",
          "2649622",
          "3006705815",
          "3033257494",
          "2017865",
          "3013921506",
          "3009380063",
          "3010972758",
          "3008159616",
          "2182208",
          "3011120183",
          "3002806603",
          "3004593495"
        ],
        "device_name": "Pacemaker/Icd/Crt Non-Implanted Components",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}