FDA Device recall Z-0458-2026

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

FDA Device
Class II
ongoing
Published 2025-11-19

On 2025-11-19 the FDA classified a Class II recall of Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 by Abbott Medical, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0458-2026
Classification	Class II
Status	ongoing
Initiated	2025-10-06
Published	2025-11-19
Last updated	2026-09-13 11:57 UTC
Company	Abbott Medical
Distribution	n/a

Product

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

Reason

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).

Identifiers

code_info	UDI/DI 05415067040763, Serial Numbers: 19400015, 19400017, 19400020, 19400021, 19400022, 19400023, 19400025, 19400026… 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, 19473834, 19473835, 19473836, 19473837, 19473838, 19473839, 19473840, 19473841, 19473842, 19473843, 19473845, 19473850, 19473851, 19473852, 19473853, 19473854, 19473855, 19473857, 19473859, 19473861, 19473862, 19473866, 19473867, 19473870, 19475756, 19475759, 19475762, 19475763, 19475765, 19475767, 19475768, 19475770, 19475771, 19475772, 19475774, 19475776, 19475777, 19475778, 19475779, 19475780, 19475781, 19475782, 19475783, 19475784, 19475785, 19475788, 19475789, 19475791, 19475793, 19475794, 19475796, 19475799, 19475800, 19475802, 19475804, 19475805, 19475807, 19475809, 19475810, 19475811, 19475812, 19475813, 19475815, 19475816, 19475818, 19475823, 19475824, 19475825, 19475826, 19475827, 19475829,

code_info

UDI/DI 05415067040763, Serial Numbers: 19400015, 19400017, 19400020, 19400021, 19400022, 19400023, 19400025, 19400026…

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, 19473834, 19473835, 19473836, 19473837, 19473838, 19473839, 19473840, 19473841, 19473842, 19473843, 19473845, 19473850, 19473851, 19473852, 19473853, 19473854, 19473855, 19473857, 19473859, 19473861, 19473862, 19473866, 19473867, 19473870, 19475756, 19475759, 19475762, 19475763, 19475765, 19475767, 19475768, 19475770, 19475771, 19475772, 19475774, 19475776, 19475777, 19475778, 19475779, 19475780, 19475781, 19475782, 19475783, 19475784, 19475785, 19475788, 19475789, 19475791, 19475793, 19475794, 19475796, 19475799, 19475800, 19475802, 19475804, 19475805, 19475807, 19475809, 19475810, 19475811, 19475812, 19475813, 19475815, 19475816, 19475818, 19475823, 19475824, 19475825, 19475826, 19475827, 19475829,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0458-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.