United StatesEterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG), Model 32400, and Liberta RC Deep Brain Stimulation (DBS) IPG, Model 62400, distributed worldwide by Abbott Medical are being recalled; affected quantities are 20,715 Eterna units and 722 Liberta units, with UDI/DI 05415067040763 and many listed serial numbers. The devices were recalled because they may experience a loss of communication with the Clinician Programmer and/or the Patient Controller.
What's being recalled
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Recalling firm: Abbott Medical, Plano, TX, United States.
How to identify it
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, 19493453, 19493454, 19493455, 19493456, 19493458, 19493459, 19493460, 19493461, 19493462, 19493463, 19493465, 19493466, 19493467, 19493468, 19493469, 19493470, 19493471, 19493472, 19493473, 19493474, 19493477, 19493478, 19493479, 19493481, 19493482, 19493484, 19493485, 19493486, 19493488, 19493489, 19493490, 19493491, 19493492, 19493493, 19524296, 19524297, 19524298, 19524299, 19524300, 19524303, 19524304, 19524305, 19524306, 19524307, 19524308, 19524309, 19524310, 19524311, 19524312, 19524313…
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
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