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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84029

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 16, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
LivaNova USA Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

Z-0868-2020
Recall number
Z-0868-2020
Initiated
November 16, 2018
Classification
Class II
Status
Terminated
Recalling firm
LivaNova USA Inc
Quantity
106 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Manufacturing material removal

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 35794, 37762, 37792, 37872, 37874, 37881, 37885, 37889, 37890, 37893, 37913, 37915, 37916, 37965, 37975, 37977, 37984, 37987, 37988, 37990, 38051, 38054, 38068, 38132, 38148, 38153, 38154, 38155, 38162, 38173, 38210, 38224, 38226, 38239, 38240, 38243, 38245, 38246, 38248, 38249, 38252, 38268, 38272, 38273, 38274, 38275, 38277, 38279, 38282, 38284, 38292, 38293, 38296, 38299, 38302, 38306, 38308, 38312, 38314, 38315, 38319, 38321, 38326, 38330, 38344, 38443, 38464, 38490, 38505, 38517, 38529, 38530, 38549, 38561, 38564, 38565, 38625, 38628, 38651, 38661, 38689, 38691, 38698, 38702, 38719, 38722, 38730, 38735, 38745, 38751, 38754, 38755, 38771, 38773, 38775, 38779, 38800, 38804, 38805, 38809, 39334, 39344, 39347, 39354, 39362, and 39731. The expiration date range is 2/25/2017-5/1/2017.

Distribution pattern

Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.

device · product 2 of 2

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
Recall number
Z-0869-2020
Initiated
November 16, 2018
Classification
Class II
Status
Terminated
Recalling firm
LivaNova USA Inc
Quantity
745 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Manufacturing material removal

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Field note

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