{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "219421",
      "product_res_number": "Z-2048-2026",
      "event_date_initiated": "2026-03-30",
      "event_date_posted": "2026-05-01",
      "recall_status": "Open, Classified",
      "res_event_number": "98679",
      "product_code": "MXD",
      "k_numbers": [
        "K231328"
      ],
      "product_description": "LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5",
      "code_info": "LUX-DX II UDI-DI: 00802526620713;\nSERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US;\nSerial Number: 104263\n109787",
      "firm_fei_number": "2124215",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5700",
      "reason_for_recall": "For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An IMPORTANT Medical Device Correction notification letter dated 3/30/26 was sent to customers.\n\nRecommendations\nAs noted previously, Boston Scientific released an update to LATITUDE Clarity on March 27, 2026 to correct this programming discrepancy. Devices impacted by this issue will be automatically corrected to the clinician assigned programming once the device successfully reconnects with LATITUDE Clarity. To confirm updated programming settings have been applied to the impacted M302/M312 device:\n\" Navigate to the patient s profile on LATITUDE Clarity;\n\" Verify that the last connection to the device occurred after March 27, 2026. If not, the patient will need to reconnect their mobile monitor;\n\" Check device programming under Counters and Settings and verify that Brady, Pause, and PVC Burden are set as desired;\n\" Complete and return the enclosed Acknowledgment Form per the instructions.\nBoston Scientific s RhythmCARE\" Support Team is available to assist HCPs with resolving this programming discrepancy, confirming programmed settings, or assisting with reconnecting a patient, either remotely or in-clinic.\n\nAdditional Information\nPatient safety remains Boston Scientific s highest priority. We recognize the impact of this device behavior on both you and your patients, and we are committed to transparent communication with physicians and other HCPs to ensure you have relevant information for managing your patients. If you have additional questions regarding the information described above or would like to report a clinical event, please contact the Boston Scientific RhythmCARE Support team. Adverse events may also be reported directly to the FDA s MedWatch Adverse Event Reporting program.\n\nUnited States RhythmCARE Support\n1.800.CARDIAC (227.3422) latitude@bsci.com",
      "product_quantity": "2 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Belgium.",
      "openfda": {
        "k_number": [
          "K193473",
          "K132649",
          "K210608",
          "K233320",
          "K253516",
          "K262735",
          "K150614",
          "K210484",
          "K190548",
          "K251221",
          "K211304",
          "K212008",
          "K240693",
          "K201865",
          "K160809",
          "K143503",
          "K221962",
          "K170628",
          "K200795",
          "K230553",
          "K230375",
          "K162855",
          "K200444",
          "K160689",
          "K171514",
          "K223630",
          "K132960",
          "K261074",
          "K231328",
          "K252593",
          "K233562",
          "K221856",
          "K163460",
          "K152995"
        ],
        "registration_number": [
          "3004185781",
          "2124215",
          "3009380063",
          "9614453",
          "3018094310",
          "3008973940",
          "1028232",
          "2182208",
          "2017865",
          "9610139",
          "9616693",
          "3015544746"
        ],
        "fei_number": [
          "3004185781",
          "2124215",
          "3009380063",
          "3002806500",
          "3002807576",
          "3018094310",
          "3008973940",
          "1028232",
          "2182208",
          "2017865",
          "3002618605",
          "3015544746"
        ],
        "device_name": "Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1025",
        "device_class": "2"
      }
    }
  ]
}