Implantable Pulse Generator Recall: Abbott Liberta RC DBS IPG
Abbott Medical is recalling Eterna SCS IPG (Model 32400) and Liberta RC DBS IPG (Model 62400) because these devices may lose communication with the Clinician Programmer or Patient Controller. About 722 units distributed worldwide are affected; the recall is identified by FDA with UDI/DI 05415067047663 and a large list of serial numbers.
| Brand | Abbott Medical |
|---|---|
| Product | Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 |
| 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). |
| Severity | moderate |
| Units affected | 11182 |
| Distribution | Worldwide distribution. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Contact your implanting clinician or device clinic to determine if your device is affected and whether any action is needed for your serial number.
- Do not attempt to reprogram or modify the device yourself; follow your clinician's instructions.
- If you experience communication loss between the device and its CP/PC, seek medical advice promptly.
- Monitor recall updates from the FDA or Abbott Medical and have your device serial number ready if contacted.
How to identify the recalled item
| Lot / date codes | UDI/DI 05415067047663, Serial Numbers: 20196493, 20196495, 20196496, 20196497, 20196498, 20196500, 20196502, 20196503, 20196504, 20196505, 20196506, 20196507, 20196508, 20196509, 20196511, 20196512, 20196513, 20196514, 20196515, 20196516, 20196517, 20207397, 20207398, 20207399, 20207400, 20207401, 20207402, 20207403, 20207405, 20207406, 20207407, 20207408, 20207409, 20207410, 20207411, 20207412, 20207413, 20207414, 20207415, 20207416, 20207417, 20207418, 20207419, 20207420, 20207421, 20207422, 20207423, 20207424, 20207425, 20207427, 20207428, 20207429, 20207430, 20207431, 20207432, 20207433, 20207434, 20207435, 20207436, 20207437, 20207438, 20207441, 20207442, 20207443, 20207444, 20207445, 20207446, 20207447, 20207448, 20207449, 20207450, 20207451, 20207452, 20207454, 20207455, 20207456, 20207457, 20207458, 20207459, 20207460, 20207461, 20207462, 20207463, 20207464, 20207465, 20207466, 20207467, 20207468, 20207469, 20207470, 20207471, 20207472, 20207473, 20207474, 20207477, 20207478, 20207481, 20207482, 20207483, 20207484, 20207485, 20207486, 20207487, 20207488, 20207489, 20207490, 20207491, 20207494, 20207495, 20207496, 20208681, 20208682, 20208683, 20208684, 20208685, 20208686, 20208687, 20208688, 20208689, 20208690, 20208691, 20208692, 20208693, 20208695, 20208696, 20208697, 20208698, 20208699, 20208701, 20208703, 20208704, 20219079, 20219080, 20219081, 20219082, 20219083, 20219084, 20219085, 20219086, 20219087, 20219088, 20219089, 20219090, 20219091, 20219092, 20219093, 20219094, 20219095, 20219096, 20219097, 20219098, 20219099, 20219100, 20219101, 20219102, 20219103, 20219104, 20219105, 20219106, 20219107, 20219108, 20219109, 20219110, 20219111, 20219113, 20219114, 20219115, 20219116, 20219117, 20219118, 20219119, 20219120, 20219121, 20219122, 20219123, 20219124, 20219126, 20219128, 20219129, 20219130, 20219131, 20219132, 20219133, 20219134, 20219135, 20219136, 20219137, 20219138, 20219139, 20219140, 20219142, 20219143, 20219144, 20219145, 20219146, 20219147, 20219148, 20219149, 20219150, 20219151, 20219152, 20219154, 20219155, 20219156, 20219157, 20219158, 20219159, 20219160, 20219162, 20219163, 20219164, 20219165, 20219166, 20219167, 20219168, 20219169, 20219171, 20219173, 20219174, 20219175, 20219176, 20219177, 20219178, 20232812, 20232814, 20232815, 20232816, 20232817, 20232818, 20232819, 20232821, 20232822, 20232824, 20232825, 20232827, 20232829, 20232830, 20232831, 20232832, 20232833, 20232834, 20232835, 20232836, 20232837, 20232838, 20232839, 20232840, 20232842, 20232844, 20232845, 20232846, 20232847, 20232848, 20232849, 20232850, 20232851, 20232852, 20232853, 20232854, 20232855, 20232856, 20232857, 20232858, 20232859, 20232861, 20232862, 20232863, 20232864, 20232865, 20232866, 20232867, 20232868, 20232869, 20232871, 20232872, 20232873, 20232874, 20232875, 20232877, 20232878, 20232879, 20232880, 20232881, 20240514, 20240516, 20240518, 20240520, 20240524, 20240528, 20240529, 20240530, 20240532, 20240533, 20240536, 20240538, 20240539, 20240543, 20240544, 20240545, 20240546, 20240547, 20240550, 20240552, 20240515, 20240517, 20240519, 20240521, 20240522, 20240526, 20240527, 20240531, 20240534, 20240535, 20240537, 20240541, 20240542, 20240551, 20237409, 20237410, 20237415, 20237416, 20237422, 20237424, 20237426, 20237429, 20237430, 20237437, 20237439, 20237442, 20237444, 20237445, 20237447, 20237453, 20237454, 20237459, 20237463, 20237470, 20237479, 20237480, 20237481, 20237484, 20237485, 20237486, 20237491, 20237494, 20237506, 20237413, 20237418, 20237419, 20237428, 20237432, 20237433, 20237434, 20237438, 20237440, 20237443, 20237449, 20237451, 20237452, 20237458, 20237461, 20237462, 20237465, 20237466, 20237475, 20237477, 20237482, 20237483, 20237487, 20237488, 20237492, 20237499, 20237500, 20237501, 20237503, 20237504, 20237407, 20237408, 20237414, 20237417, 20237421, 20237423, 20237427, 20237435, 20237436, 20237441, 20237446, 20237448, 20237450, 20237455, 20237456, 20237457, 20237460, 20237467, 20237468, 20237469, 20237471, 20237472, 20237476, 20237478, 20237489, 20237490, 20237493, 20237496, 20237497, 20237498, 20237505, 20266863, 20266864, 20266866, 20266867, 20266868, 20266869, 20266871, 20266872, 20266874, 20266875, 20266877, 20266878, 20266879, 20266880, 20266881, 20266883, 20266884, 20266885, 20266886, 20266887, 20266888, 20266889, 20266891, 20266892, 20266894, 20266895, 20266896, 20266897, 20266898, 20266899, 20266900, 20266901, 20266902, 20267204, 20267205, 20267206, 20267209, 20267210, 20267211, 20267213, 20267214, 20267215, 20267218, 20267225, 20267229, 20267231, 20267234, 20267235, 20267238, 20267240, 20267242, 20267245, 20267250, 20267255, 20267264, 20267265, 20267268, 20267270, 20267271, 20267275, 20267277, 20267278, 20267284, 20267286, 20267291, 20267294, 20267295, 20267297, 20267299, 20267301, 20267302, 20267303, 20267208, 20267216, 20267217, 20267219, 20267220, 20267222, 20267224, 20267226, 20267227, 20267230, 20267232, 20267236, 20267239, 20267241, 20267243, 20267244, 20267246, 20267247, 20267248, 20267249, 20267251, 20267252, 20267254, 20267256, 20267258, 20267260, 20267261, 20267262, 20267263, 20267266, 20267267, 20267272, 20267273, 20267274, 20267276, 20267279, 20267280, 20267281, 20267282, 20267283, 20267287, 20267288, 20267289, 20267290, 20267292, 20267293, 20267296, 20267298, 20267300, 20365319, 20365320, 20365321, 20365322, 20365323, 20365325, 20365326, 20365329, 20365330, 20365333, 20365337, 20365338, 20365339, 20365340, 20365341, 20365342, 20365343, 20365348, 20365350, 20365351, 20365355, 20365361, 20365362, 20365363, 20365364, 20365371, 20365373, 20365379, 20365383, 20365384, 20365385, 20365386, 20365388, 20365389, 20365391, 20365392, 20365393, 20365394, 20365395, 20365396, 20365397, 20365398, 20365401, 20365403, 20365409, 20365410, 20365411, 20365414, 20365416, 20365324, 20365327, 20365328, 20365331, 20365332, 20365334, 20365335, 20365336, 20365344, 20365345, 20365346, 20365347, 20365349, 20365352, 20365353, 20365356, 20365359, 20365360, 20365365, 20365366, 20365367, 20365368, 20365369, 20365370, 20365372, 20365375, 20365376, 20365377, 20365378, 20365380, 20365381, 20365382, 20365387, 20365390, 20365399, 20365400, 20365402, 20365404, 20365405, 20365406, 20365407, 20365408, 20365412, 20365415, 20365417, 20367788, 20367789, 20367791, 20367794, 20367796, 20367798, 20367799, 20367801, 20367804, 20367806, 20367807, 20367810, 20367813, 20367815, 20367820, 20367821, 20367822, 20367823, 20367824, 20367825, 20367827, 20367830, 20367834, 20367835, 20367836, 20367839, 20367840, 20367841, 20367843, 20367844, 20367845, 20367847, 20367850, 20367853, 20367860, 20367863, 20367864, 20367865, 20367868, 20367870, 20367871, 20367872, 20367874, 20367877, 20367878, 20367879, 20367880, 20367882, 20367886, 20367787, 20367795, 20367797, 20367819, 20367828, 20367832, 20367849, 20367858, 20367861, 20367862, 20367866, 20367867, 20367869, 20367873, 20367876, 20385679, 20385682, 20385686, 20385687, 20385689, 20385696, 20385697, 20385701, 20385706, 20385707, 20385708, 20385714, 20385715, 20385724, 20385726, 20385727, 20385728, 20385730, 20385731, 20385733, 20385735, 20385740, 20385743, 20385745, 20385749, 20385750, 20385753, 20385755, 20385758, 20385760, 20385763, 20385766, 20385767, 20385768, 20385769, 20232841. |
|---|---|
| Lot / date codes | Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region) |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.