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Home › FDA recalls › Eterna SCS IPG
CLASS II · ModerateFDA

Abbott Medical recalls Eterna SCS IPG

📅 Oct 6, 2025 · 📍 See notice
Recalling company
Abbott Medical
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).
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 6, 2025
Reported
Nov 19, 2025
Distribution
Worldwide distribution.
Status
Ongoing
Quantity
20715 units
Lot / codes
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, 19475830, 19475832, 19475833, 19475834, 19475835, 19493395, 19493397, 19493398, 19493399, 19493401, 19493402, 19493403, 19493404, 19493405, 19493406, 19493407, 19493408, 19493410, 19493411, 19493415, 19493416, 19493417, 19493418, 19493421, 19493422, 19493423, 19493424, 19493425, 19493426, 19493427, 19493428, 19493429, 19493431, 19493432, 19493433, 19493434, 19493435, 19493436, 19493437, 19493438, 19493439, 19493440, 19493442, 19493445, 19493446, 19493447, 19493448, 19493449, 19493450, 19493451,
Company location
Plano, TX
Recall type
Voluntary: Firm initiated
Recall number
Z-0458-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0458-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.