FDA Medical devices recall ·
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 recall
- Recall number
- Z-0458-2026
- Date
- (initiated October 6, 2025)
- Company / brand
- Abbott Medical
6901 Preston Rd, Plano, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20715 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Why was it recalled?
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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 1
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0458-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.