Deep brain stimulators recalled over loss of programmer communication
Abbott Medical is recalling 722 Liberta RC deep brain stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: an implanted stimulator that cannot be reprogrammed or interrogated is a hazard, and no injuries are reported.
Plain-English summary
The Abbott Liberta RC DBS Implantable Pulse Generator, model 62400, is being recalled.
The firm has identified a potential issue affecting Eterna Spinal Cord Stimulation IPGs (model 32400) and Liberta RC Deep Brain Stimulation IPGs (model 62400). These devices may experience a loss of communication with the Clinician Programmer and/or the Patient Controller.
The recall covers 722 units carrying UDI/DI 05415067047663, distributed worldwide. The FDA has classified the action as Class II.
Losing the programming link means therapy settings cannot be adjusted or checked on an implanted device. The enforcement record reports no injuries. Patients and clinicians should follow Abbott's instructions.
The recalled product
- Product
- Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
- Manufacturer
- Abbott Medical
- Category
- Medical Device — Neurostimulator
- Affected units
- 722
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 05415067047663
- Serial Numbers: 20196493
- 20196495
- 20196496
- 20196497
- 20196498
- 20196500
- 20196502
- 20196503
- 20196504
- 20196505
- 20196506
- 20196507
- 20196508
- 20196509
- 20196511
- 20196512
- 20196513
- 20196514
- 20196515
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Abbott Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Abbott Medical
See all →- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- HighSpinal cord stimulators recalled over loss of programmer communication
FDA (Devices) · 2025-11-19
- HighAbbott Aveir DR Leadless Pacemaker Recalled for Battery Failure Risk
FDA (Devices) · 2025-04-23
- HighMerlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing
FDA (Devices) · 2025-01-01
- ModerateHeart Device Transmitter Fails to Update Software After Power Interruption
FDA (Devices) · 2024-12-04
Same hazard · communication loss
See all →- ModerateBeckman Coulter DxI 9000 Access Immunoassay Analyzer communication loss
FDA (Devices) · 2025-04-30
- HighGE Healthcare Recalls CARESCAPE Monitor B850 Due to Communication Loss
FDA (Devices) · 2014-02-12
- ModerateCareFusion Recalls Alaris PC Units Due to Voltage and Communication Issues
FDA (Devices) · 2013-08-14