FDA Device recall Z-0869-2020

Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus ne…

FDA Device
Class II
terminated
Published 2020-02-05

On 2020-02-05 the FDA classified a Class II recall of Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus ne… by Livanova Usa, citing 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 a….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0869-2020
Classification	Class II
Status	terminated
Initiated	2018-11-16
Published	2020-02-05
Last updated	2026-09-13 11:55 UTC
Company	Livanova Usa
Distribution	US

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.

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.

Identifiers

code_info	Serial numbers 36519, 36766, 36770, 36776, 36791, 36794, 36800, 36802, 36821, 36824, 36833, 36835, 36845, 36847, 36849,… 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, 375

code_info

Serial numbers 36519, 36766, 36770, 36776, 36791, 36794, 36800, 36802, 36821, 36824, 36833, 36835, 36845, 36847, 36849,…

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, 375

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0869-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.