{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216515", "product_res_number": "Z-0459-2026", "event_date_initiated": "2025-10-06", "event_date_posted": "2025-11-07", "recall_status": "Open, Classified", "res_event_number": "97754", "product_code": "MHY", "pma_numbers": [ "P140009" ], "product_description": "Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400", "code_info": "UDI/DI 05415067047663, Serial Numbers: 20196493, 20196495, 20196496, 20196497, 20196498, 20196500, 20196502, 20196503, 20196504, 20196505, 20196506, 20196507, 20196508, 20196509, 20196511, 20196512, 20196513, 20196514, 20196515, 20196516, 20196517, 20207397, 20207398, 20207399, 20207400, 20207401, 20207402, 20207403, 20207405, 20207406, 20207407, 20207408, 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"city": "Plano", "state": "TX", "postal_code": "75024-2508", "additional_info_contact": "Carolina Castano\n512-286-4021", "reason_for_recall": "There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).", "root_cause_description": "Process control", "action": "On 10/01/2025 Abbott issued an URGENT MEDCIAL DEVICE RECALL NOTICE to its consignees via email and mail. The notice explained the issue and requested the devices not be implanted, and informed the consignee that a representative would remove the affected devices. \nAbbott issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/06/2025 via email and mail using a traceable means. The notice explained the issued and provided the following patient management guidance: \n\"There are various factors that can lead to BLE communication loss between an IPG and CP/PC, and not all instances are related to this identified component issue. If the PC and/or CP is unable to communicate with the patient's IPG, the troubleshooting steps outlined below, as well as those provided in the Troubleshooting section of CP (Model 55600) and PC (Models 55500, 3876) Instructions for Use may help restore communication.\n\" Use the CP to confirm communication with the IPG during the implant procedure and verify that BLE connectivity is functioning. In some cases, this issue may be detected prior to implantation.\n\" Ensure that Bluetooth wireless connectivity is enabled on both the CP and PC.\n\" Reduce the distance between the CP/PC and the IPG and confirm there are no physical obstructions. Maintaining a clear line of sight may improve communication.\n\" Move away from potential sources of wireless interference, such as household appliances, Wi-Fi routers, electrical equipment, or other wireless devices.\n\" Do not operate other wireless devices at the same time and disconnect any Bluetooth wireless technology media accessories. \n\" If the problem persists, contact your Abbott representative or Abbott Technical Support (1-800-727-7846) for help to determine whether the inability to communicate is related to this issue.\" \nActions to be Taken: \nPlease return a completed Acknowledgement Form and maintain a record of this notice along with a copy of the completed Acknowledgement Form.", "product_quantity": "722 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "pma_number": [ "P960009", "P140009" ], "registration_number": [ "2024311", "3005210579", "3019807891", "3010531069", "1627487", "3018094310", "9616693", "3003120897", "2182207", "3010086866", "3006705815", "2124215", "3013023969", "2649622", "2648729", "3003335547", "2133772", "3003477135", "1928237", "3004209178", "2183744", "3006630150", "3010972758", "2133641", "3015924373", "3004593495", "3005160949", "3009380063", "3010052483", "2135338", "3038429246" ], "fei_number": [ "3005700659", "3002618605", "2024311", "3005210579", "3019807891", "3010531069", "1627487", "3018094310", "3003120897", "2182207", "3010086866", "3006705815", "2124215", "3013023969", "2649622", "3000203466", "2648729", "3003335547", "3003477135", "1928237", "3006630150", "3000209794", "2183744", "3004369318", "3010972758", "3015924373", "3004593495", "3005160949", "3009380063", "3010052483", "3038429246" ], "device_name": "Stimulator, Electrical, Implanted, For Parkinsonian Tremor", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }