[pending] Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Pending LLM rewrite. Source: FDA_DEVICE Z-0459-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
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).
The recalled product
- Product
- Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
- Manufacturer
- Abbott Medical
- Category
- Medical Device — Devices
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.
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