Liberta RC DBS IPG (Abbott) – potential device issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Brand
Abbott Medical
Lot Codes / Batch Numbers
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.
Products Sold
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.
Abbott Medical is recalling Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 due to There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain S. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
On 10/01/2025 Abbott issued an URGENT MEDCIAL DEVICE RECALL NOTICE to its consignees via email and mail. The notice explained the issue and requested the devices not be implanted, and informed the consignee that a representative would remove the affected devices. Abbott issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/06/2025 via email and mail using a traceable means. The notice explained the issued and provided the following patient management guidance: "There are various factors that can lead to BLE communication loss between an IPG and CP/PC, and not all instances are related to this identified component issue. If the PC and/or CP is unable to communicate with the patient's IPG, the troubleshooting steps outlined below, as well as those provided in the Troubleshooting section of CP (Model 55600) and PC (Models 55500, 3876) Instructions for Use may help restore communication. " Use the CP to confirm communication with the IPG during the implant procedure and verify that BLE connectivity is functioning. In some cases, this issue may be detected prior to implantation. " Ensure that Bluetooth wireless connectivity is enabled on both the CP and PC. " Reduce the distance between the CP/PC and the IPG and confirm there are no physical obstructions. Maintaining a clear line of sight may improve communication. " Move away from potential sources of wireless interference, such as household appliances, Wi-Fi routers, electrical equipment, or other wireless devices. " Do not operate other wireless devices at the same time and disconnect any Bluetooth wireless technology media accessories. " If the problem persists, contact your Abbott representative or Abbott Technical Support (1-800-727-7846) for help to determine whether the inability to communicate is related to this issue." Actions to be Taken: Please return a completed Acknowledgement Form and maintain a record of this notice along with a copy of the completed Acknowledgement Form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026