FDA recall Z-0458-2026

Product

Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

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).

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2025-10-06

Report date

2025-11-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plano, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2026