Eterna SCS IPG — Class II medical device recall Z-0458-2026
Ongoing recall by Abbott Medical, reported 2025-11-19. There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs),
| Recall number | Z-0458-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Plano, TX, United States |
| Recall initiated | 2025-10-06 |
| Classified | 2025-11-07 |
| Reported by FDA | 2025-11-19 |
| Quantity | 20,715 units |
| UPC / GTIN / UDI-DI | 05415067040763 |
| Serial numbers | 19400015, 19400017, 19400020, 19400021, 19400022, 19400023, 19400025, 19400026, 19400029, 19400030, 19400031, 19400033, 19400035, 19400037, 19400038, 19400039, 19400040, 19400041, 19400042, 19400043, 19400044, 19400045, 19400048, 19400051, 19473833 and 475 more |
| Model numbers | 32400 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0458-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.