# FDA recall Z-0458-2026

> **Abbott Medical** · Class II · device recall initiated 2025-10-06.

## 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

- **Recall number:** Z-0458-2026
- **Recalling firm:** Abbott Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-06
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plano, TX, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0458-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0458-2026. Source: US FDA. Licensed CC0.

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