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.
Enforcement
- Recall Number
- Z-0869-2020
- Event ID
- 84029
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- LivaNova USA Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 5, 2020
- Initiation Date
- November 16, 2018
- Classification Date
- January 27, 2020
- Termination Date
- December 12, 2022
- Address
- 100 Cyberonics Blvd, N/A, Houston, TX, 77058-2069, United States
Description
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.
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.
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, 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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 US nationwide, including Puerto Rico. There was no foreign/military/government consignees.
745 devices