Class 2 Device Recall Abbott Liberta

• Date Initiated by Firm: October 06, 2025
• Date Posted: November 07, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0459-2026
• Recall Event ID: 97754
• PMA Number: P140009
• Product Classification: Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
• Product: Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
• Code Information: 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, 20207409, 20207410, 20207411, 20207412, 20207413, 20207414, 20207415, 20207416, 20207417, 20207418, 20207419, 20207420, 20207421, 20207422, 20207423, 20207424, 20207425, 20207427, 20207428, 20207429, 20207430, 20207431, 20207432, 20207433, 20207434, 20207435, 20207436, 20207437, 20207438, 20207441, 20207442, 20207443, 20207444, 20207445, 20207446, 20207447, 20207448, 20207449, 20207450, 20207451, 20207452, 20207454, 20207455, 20207456, 20207457, 20207458, 20207459, 20207460, 20207461, 20207462, 20207463, 20207464, 20207465, 20207466, 20207467, 20207468, 20207469, 20207470, 20207471, 20207472, 20207473, 20207474, 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• FEI Number: 1627487
• Recalling Firm/ Manufacturer: Abbott Medical; 6901 Preston Rd; Plano TX 75024-2508
• For Additional Information Contact: Carolina Castano; 512-286-4021
• Manufacturer 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).
• FDA Determined Cause: 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. Abbott 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: "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. " 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. " Ensure that Bluetooth wireless connectivity is enabled on both the CP and PC. " 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. " Move away from potential sources of wireless interference, such as household appliances, Wi-Fi routers, electrical equipment, or other wireless devices. " Do not operate other wireless devices at the same time and disconnect any Bluetooth wireless technology media accessories. " 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." Actions to be Taken: Please return a completed Acknowledgement Form and maintain a record of this notice along with a copy of the completed Acknowledgement Form.
• Quantity in Commerce: 722 units
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MHY