Home › Device types › LYJ
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA product code LYJ · Class 3 · Unknown
29
Registered devices
51,885
Adverse events
37
Recalls
0
510(k) clearances
Devices with this code
VNS Therapy® Pulse Model 102 Generator — LIVANOVA USA, INC.VNS Therapy® Programmer, Model 3000 v1.0 — LIVANOVA USA, INC.VNS Therapy® Model 250 v11.0 Programming Software — LIVANOVA USA, INC.VNS Therapy® Programmer, Model 3000 v1.6.2 — LIVANOVA USA, INC.VNS Therapy® Model 302 Lead — LIVANOVA USA, INC.VNS Therapy® Model 250 v8.1 Programming Software (X50) — LIVANOVA USA, INC.VNS Therapy® Model 502 Accessory Pack — LIVANOVA USA, INC.VNS Therapy® Programmer, Model 3000 v1.5 — LIVANOVA USA, INC.VNS Therapy® Pulse Duo Model 102R Generator — LIVANOVA USA, INC.VNS Therapy® SenTiva™ Model 1000 Generator — LIVANOVA USA, INC.VNS Therapy® Model 250 v10.0 Programming Software — LIVANOVA USA, INC.VNS Therapy™ Programmer, Model 3100 v1.1.0 — LIVANOVA USA, INC.VNS Therapy® PerenniaFLEX® Model 304 Lead — LIVANOVA USA, INC.VNS Therapy® Model 250 v10.0 Programming Software — LIVANOVA USA, INC.VNS Therapy® Demipulse® Model 103 Generator — LIVANOVA USA, INC.VNS Therapy® Model 250 v8.1 Programming Software (X5) — LIVANOVA USA, INC.VNS Therapy® Model 302 Lead — LIVANOVA USA, INC.VNS Therapy® AspireSR® Model 106 Generator — LIVANOVA USA, INC.VNS Therapy® PerenniaFLEX® Model 304 Lead — LIVANOVA USA, INC.VNS Therapy® PerenniaDURA® Model 303 Lead — LIVANOVA USA, INC.VNS Therapy® Programming Wand Model 2000 — LIVANOVA USA, INC.VNS Therapy® Demipulse Duo® Model 104 Generator — LIVANOVA USA, INC.VNS Therapy® PerenniaDURA® Model 303 Lead — LIVANOVA USA, INC.VNS Therapy® Model 250 v11.0 Programming Software — LIVANOVA USA, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-03 | LivaNova USA, Inc. | Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. |
| 2025-01-03 | LivaNova USA, Inc. | Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. |
| 2024-12-12 | LivaNova USA, Inc. | Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed positio |
| 2024-12-12 | LivaNova USA, Inc. | Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed positio |
| 2021-12-02 | LivaNova USA, Inc. | A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing beco |
| 2020-11-12 | LivaNova USA Inc | During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated. |
| 2020-09-28 | LivaNova USA Inc | Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy progra |
| 2020-02-04 | LivaNova USA Inc | False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-ses |
| 2019-08-22 | LivaNova USA Inc | Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If |
| 2019-08-13 | LivaNova USA Inc | Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications. |
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