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Lower risk Medical device recall · FDA · Published November 16, 2018

Cyberonics VNS Therapy AspireSR Model 106 Generator Battery Depletion Recall

Cyberonics recalls VNS Therapy AspireSR Model 106 generators with serial numbers 36519-43201 due to premature battery depletion from electrical leakage in circuit boards.

🇺🇸 FDA recall #Z-0869-2020Medical deviceCyberonics ›
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Recalling firmLivaNova USA Inc100 Cyberonics Blvd · Houston, TX 77058-2069
✎ GovInfoNow plain-language explainer

What happened, in plain English

Cyberonics is recalling VNS Therapy AspireSR Model 106 generators that may experience premature battery depletion. This issue could lead to the device stopping working unexpectedly, potentially affecting medical treatment for patients with vagus nerve stimulation. Read more at govinfonow.com/recall/69460-cyberonics-vns-therapy-aspiresr-model-106-generator-battery-depletion-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/69460-cyberonics-vns-therapy-aspiresr-model-106-generator-battery-depletion-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0869-2020

Cite this page

“Cyberonics VNS Therapy AspireSR Model 106 Generator Battery Depletion Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69460-cyberonics-vns-therapy-aspiresr-model-106-generator-battery-depletion-recall. Based on FDA recall #Z-0869-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0869-2020%22&limit=1).

Why it’s dangerous

The generators have electrical leakage on the circuit boards that causes premature battery depletion. This means the device may stop working unexpectedly, which could disrupt medical treatment for patients using vagus nerve stimulation.

Who’s affected

Patients using Cyberonics VNS Therapy AspireSR Model 106 generators with the listed serial numbers are affected. Those with the device are most at risk as the battery may deplete unexpectedly.

How to tell if you have this one

Check your Cyberonics VNS Therapy AspireSR Model 106 generator for serial numbers listed in the range 36519 to 43201. The device was sold between September 30, 2016, and February 28, 2017.

  • Brand
    Cyberonics
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.
Recall numberProduct, codes & lotsQuantity
Z-0868-2020Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.; 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 2/25/2017-5/1/2017.106 devices
Z-0869-2020Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.; 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 9/30/2016-2/28/2017.745 devices
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Look for the serial number on your Cyberonics VNS Therapy AspireSR Model 106 generator. If it matches the list of numbers from 36519 to 43201, it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 4.1 years after the firm started it.

1. Firm started the recall: Nov 16, 201812. FDA classified it Class II: Jan 27, 202023. Published in FDA’s Enforcement Report: Feb 5, 202034. FDA terminated the recall: Dec 12, 2022420182022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0869-2020 (November 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0869-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA