Liberta RC DBS IPG (Implantable Pulse Generator), Model… recallZ-0459-2026 · Abbott Medical · initiated Oct 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0459-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 6, 2025
- Posted by the FDA
- Nov 7, 2025
- Recalling firm
- Abbott Medical
- Quantity
- 722 units
- Product code
- MHY
- FDA submissions
- P140009
- Distribution
- Worldwide distribution.
Product description
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Code information (models, lots, serial numbers)
Show the full code information (7k characters)
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Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Liberta RC™ 62400Advanced Neuromodulation Systems, Inc. · Stimulator, electrical, implanted, for essential tremor2 recalls1 death103 reports
Other devices under the same FDA submission
23 devices cleared under P140009 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Infinity™ 6662St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths803 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths751 reports
- Infinity™ 7St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 recalls3 deaths368 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR406 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall10 deaths306 reports
- Infinity™ 6660St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR5 deaths312 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall226 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR268 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR263 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR237 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR5 deaths178 reports
- Infinity™ 5St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 recalls28 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97754).
- Z-0458-2026 · Open, ClassifiedEterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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