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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Livanova Usa
- SenTiva, REF: 1000
FDA Device · Class II · 2025-02-12 · Livanova Usa - SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation
FDA Device · Class II · 2025-02-12 · Livanova Usa - Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: T…
FDA Device · Class II · 2025-02-05 · Livanova Usa - Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product De…
FDA Device · Class II · 2025-02-05 · Livanova Usa - Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303
FDA Device · Class II · 2022-02-09 · Livanova Usa
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.