Z-0459-2026Class II

Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400

Name: Z-0459-2026 Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Creator: Abbott Medical
Published: 2025-10-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-10-06 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Medical began a recall of Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 on 2025-10-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0459-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-06
Posted: 2025-11-07
Recalling firm: Abbott Medical
Product: Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
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 tag: manufacturing process
FDA root 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.
Product codes and lots: 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, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0459-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0458-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07
Z-0459-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)