Device product
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
Z-0869-2020
Product summary
- Firm
- LivaNova USA Inc
- Event
- Event 84029
- Status
- Terminated
- Classification
- Class II
- Quantity
- 745 devices
- Official record key
device-enforcement:Z-0869-2020
Official wording
Reason: This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.
Code information: Serial numbers 36519, 36766, 36770, 36776, 36791, 36794, 36800, 36802, 36821, 36824, 36833, 36835, 36845, 36847, 36849, 36869, 36873, 36932, 36935, 36940, 36947, 36951, 36954, 36959, 36961, 36962, 36963, 36964, 36965, 36972, 36981, 36998, 37003, 37014, 37015, 37016, 37024, 37025, 37052, 37095, 37110, 37111, 37116, 37123, 37149, 37151, 37156, 37181, 37213, 37231, 37234, 37239, 37248, 37250, 37253, 37258, 37263, 37270, 37294, 37296, 37297, 37301, 37302, 37310, 37328, 37329, 37331, 37332, 37334, 37338, 37339, 37351, 37353, 37355, 37359, 37360, 37362, 37365, 37371, 37376, 37378, 37383, 37389, 37391, 37395, 37396, 37397, 37402, 37403, 37405, 37409, 37410, 37411, 37414, 37417, 37420, 37421, 37422, 37424, 37425, 37431, 37435, 37439, 37445, 37446, 37449, 37454, 37455, 37458, 37461, 37464, 37466, 37471, 37472, 37480, 37482, 37487, 37488, 37489, 37490, 37498, 37501, 37502, 37505, 37507, 37508, 37510, 37512, 37530, 37540, 37548, 37551, 37559, 37561, 37563, 37564, 37566, 37567, 37572, 37574, 37576, 37577, 37579, 37585, 37587, 37591, 37601, 37607, 37611, 37615, 37634, 37639, 37649, 37662, 37663, 37671, 37672, 37676, 37677, 37678, 37682, 37683, 37689, 37697, 37706, 37708, 37710, 37720, 37723, 37724, 37727, 37730, 37733, 37736, 37738, 37908, 37909, 37920, 37925, 37941, 38091, 38105, 38126, 38212, 38215, 38437, 38446, 38494, 38614, 38657, 38671, 38990, 39025, 39032, 39057, 39068, 39069, 39079, 39261, 39263, 39286, 39340, 39341, 39390, 39412, 39415, 39420, 39421, 39429, 39455, 39463, 39466, 39467, 39470, 39473, 39475, 39477, 39486, 39490, 39499, 39505, 39511, 39532, 39636, 39664, 39906, 39911, 39953, 39970, 40007, 40017, 40036, 40081, 40104, 40116, 40145, 40149, 40159, 40248, 40270, 40280, 40306, 40314, 40320, 40340, 40345, 40346, 40347, 40353, 40355, 40401, 40404, 40426, 40454, 40481, 40482, 40486, 40491, 40492, 40494, 40499, 40503, 40513, 40516, 40517, 40521, 40522, 40528, 40532, 40533, 40534, 40537, 40538, 40540, 40542, 40544, 40551, 40557, 40563, 40565, 40569, 40570, 40572, 40573, 40574, 40582, 40585, 40590, 40591, 40595, 40611, 40619, 40627, 40633, 40640, 40643, 40664, 40676, 40684, 40692, 40694, 40696, 40708, 40718, 40723, 40731, 40736, 40737, 40741, 40750, 40753, 40755, 40757, 40762, 40767, 40769, 40770, 40772, 40774, 40777, 40778, 40780, 40781, 40783, 40784, 40786, 40788, 40789, 40790, 40792, 40793, 40794, 40795, 40801, 40802, 40804, 40808, 40809, 40822, 40823, 40824, 40830, 40834, 40838, 40839, 40840, 40844, 40845, 40846, 40851, 40853, 40854, 40856, 40857, 40861, 40870, 40871, 40873, 40874, 40879, 40881, 40883, 40888, 40894, 40895, 40912, 40919, 40921, 40927, 40934, 40935, 40942, 40943, 40971, 40983, 40993, 41010, 41032, 41039, 41044, 41048, 41051, 41059, 41060, 41065, 41071, 41075, 41078, 41079, 41082, 41083, 41084, 41088, 41090, 41104, 41108, 41113, 41114, 41118, 41120, 41124, 41130, 41133, 41137, 41146, 41148, 41149, 41150, 41157, 41159, 41160, 41169, 41172, 41173, 41178, 41180, 41182, 41195, 41196, 41199, 41200, 41202, 41207, 41209, 41229, 41240, 41246, 41249, 41250, 41253, 41254, 41255, 41264, 41266, 41271, 41283, 41290, 41299, 41301, 41320, 41321, 41322, 41323, 41324, 41326, 41327, 41328, 41347, 41348, 41351, 41354, 41357, 41359, 41368, 41370, 41374, 41380, 41390, 41394, 41413, 41422, 41468, 41470, 41472, 41483, 41487, 41488, 41496, 41506, 41508, 41517, 41519, 41524, 41540, 41547, 41552, 41555, 41559, 41569, 41577, 41589, 41594, 41598, 41601, 41609, 41612, 41617, 41626, 41627, 41629, 41637, 41640, 41645, 41654, 41656, 41661, 41663, 41665, 41671, 41673, 41692, 41696, 41700, 41706, 41740, 41749, 41753, 41756, 41759, 41768, 41773, 41776, 41779, 41791, 41823, 41832, 41833, 41840, 41852, 41872, 41874, 41875, 41879, 41881, 41885, 41905, 41907, 41911, 41926, 41929, 41931, 41932, 41933, 41936, 41943, 41944, 41946, 41953, 41957, 41973, 41979, 42005, 42021, 42036, 42043, 42046, 42051, 42069, 42133, 42134, 42144, 42150, 42154, 42155, 42160, 42177, 42181, 42182, 42186, 42199, 42202, 42219, 42220, 42223, 42224, 42225, 42233, 42234, 42242, 42247, 42255, 42259, 42267, 42268, 42269, 42274, 42292, 42316, 42326, 42336, 42347, 42353, 42354, 42356, 42361, 42387, 42391, 42392, 42405, 42415, 42417, 42428, 42466, 42504, 42505, 42514, 42523, 42528, 42529, 42537, 42539, 42565, 42567, 42568, 42571, 42572, 42579, 42587, 42588, 42592, 42593, 42594, 42595, 42599, 42600, 42601, 42605, 42606, 42608, 42610, 42611, 42613, 42615, 42619, 42624, 42625, 42627, 42629, 42631, 42632, 42633, 42634, 42635, 42636, 42641, 42642, 42643, 42644, 42645, 42647, 42654, 42657, 42658, 42659, 42664, 42666, 42667, 42681, 42685, 42689, 42696, 42697, 42698, 42702, 42703, 42706, 42711, 42713, 42718, 42719, 42720, 42721, 42722, 42725, 42727, 42733, 42735, 42738, 42739, 42746, 42747, 42750, 42754, 42756, 42758, 42761, 42763, 42767, 42773, 42776, 42778, 42781, 42784, 42785, 42787, 42788, 42789, 42811, 42820, 42834, 42835, 42839, 42840, 42844, 42847, 42861, 42862, 42865, 42866, 42868, 42869, 42871, 42873, 42876, 42877, 42880, 42881, 42887, 42888, 42890, 42892, 42893, 42895, 42900, 42902, 42920, 42934, 42945, 42962, 43003, 43012, 43025, 43031, 43032, 43038, 43095, 43102, 43103, 43107, 43109, 43115, 43118, 43129, 43136, 43140, 43144, 43151, 43157, 43165, 43167, 43169, 43172, 43177, 43178, and 43201. The expiration date range is 9/30/2016-2/28/2017.
Distribution pattern: Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.
Derived failure modes
-
Unknown
This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.