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VNS Therapy® AspireSR® Model 106 Generator
LIVANOVA USA, INC. · Model 106 · UDI-DI 05425025750061
LYJ
Prescription
0
510(k) clearances
51,991
Adverse events (2,918 deaths)
37
Recalls
1
Facilities
Description
Implantable Pulse Generator
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 position, which may result |
| 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 position, which may result |
| 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 becomes completely breac |
| 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 programmers with software |
| 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-session re-interrogatio |
| 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 a device experiences |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.