{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "192639",
      "product_res_number": "Z-0988-2022",
      "event_date_initiated": "2022-03-10",
      "event_date_created": "2022-04-21",
      "recall_status": "Open, Classified",
      "res_event_number": "89825",
      "product_code": "LWS",
      "pma_numbers": [
        "P910023S423"
      ],
      "product_description": "Gallant DR Implantable Cardioverter Defibrillator\nREF # CDDRA500Q",
      "code_info": "REF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material#  600115496 UDI# 05415067032003",
      "firm_fei_number": "2017865",
      "recalling_firm": "St. Jude Medical, Cardiac Rhythm Management Division",
      "address_1": "15900 Valley View Ct",
      "city": "Sylmar",
      "state": "CA",
      "postal_code": "91342-3577",
      "additional_info_contact": "Ms. Alicia Swanson,\n408-845-3427",
      "reason_for_recall": "Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to\nenter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.",
      "root_cause_description": "Component design/selection",
      "action": "Abbott issued a Safety Notification For a subset of Gallant ICDS and CRT-D, Models CDVRA500Q, CDDRA500Q and CDHFA500Q on March 10, 2022. Notification was hand delivered in US.\n\nThe notification includes the Patient Management Recommendations:\n\n-As the devices are unable to be followed using remote monitoring via Bluetooth connectivity, follow-ups should be conducted in-clinic using inductive telemetry.\n- Abbott has developed a process to attempt recovery of Bluetooth communication via a device firmware upgrade. If remote monitoring via Bluetooth communication is desired, please work with your local Abbott representative to schedule a firmware upgrade.\n\nPlease complete and return the included Acknowledgement Form to CRMNotification@abbott.com and maintain a record of this notice to ensure\neffectiveness of the communication.\n\nFor any question, please contact Abbott Technical Support at 1-800-722-3774 (U.S.).",
      "product_quantity": "1",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of  FL, KY and the country of France, Czech Republic.",
      "openfda": {
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        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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