# P970003: VNS Therapy System

- Pathway: PMA
- Applicant: LivaNova USA, Inc.
- Decided: Jul 16, 1997 after 170 days
- Product code: LYJ (Stimulator, Autonomic Nerve, Implanted For Epilepsy)
- Device class: 3
- Recalls of this device: 30 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jan 3, 2025 · Class II · Z-1068-2025: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
- Jan 3, 2025 · Class II · Z-1067-2025: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
- Dec 12, 2024 · Class II · Z-1072-2025: 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 in patients returnin
- Dec 2, 2021 · Class II · Z-0532-2022: 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 breached, the patient may
- Sep 28, 2020 · Class II · Z-0462-2021: 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 version 11.0.4.
- Feb 4, 2020 · Class II · Z-1563-2020: 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-interrogation performed. Users i
- Aug 22, 2019 · Class I · Z-0561-2020: 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 this issue, this ma
- Aug 13, 2019 · Class II · Z-1118-2020: Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
- Nov 16, 2018 · Class II · Z-0346-2020: Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes th
- Nov 16, 2018 · Class II · Z-0663-2020: This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnost
- Nov 16, 2018 · Class II · Z-0869-2020: 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 Mode
- Nov 16, 2018 · Class II · Z-0868-2020: 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 Mode
- Jan 24, 2018 · Class II · Z-2572-2018: Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
- Dec 2, 2017 · Class II · Z-0555-2018: Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
- Nov 13, 2017 · Class II · Z-2255-2018: Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead t
- Dec 18, 2015 · Class II · Z-0659-2016: Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output i
- Nov 18, 2015 · Class II · Z-0645-2016: Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.
- Oct 7, 2015 · Class II · Z-0280-2016: Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
- Nov 20, 2014 · Class II · Z-0858-2015: The recalled product was distributed with an incorrect serial number printed on the device's label.
- Aug 12, 2011 · Not classified · Z-0210-2012: The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can du
- May 6, 2011 · Not classified · Z-0005-2012: An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version
- May 6, 2011 · Not classified · Z-0006-2012: An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version
- Apr 6, 2010 · Not classified · Z-1591-2010: Battery life projection is inaccurate.
- Feb 7, 2008 · Not classified · Z-0994-2009: Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference resulting in the loss of stimulation.
- Feb 7, 2008 · Not classified · Z-0995-2009: Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference, resulting in the loss of stimulation.
- Aug 2, 2007 · Not classified · Z-0171-2008: Dissolution/Fractures to the leads of the VNS Therapy System
- Aug 2, 2007 · Not classified · Z-0172-2008: Dissolution/Fractures to the leads of the VNS Therapy System
- Aug 2, 2007 · Not classified · Z-0173-2008: Dissolution/Fractures to the leads of the VNS Therapy System
- Oct 17, 2006 · Not classified · Z-0342-2007: During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
- Oct 17, 2006 · Not classified · Z-0341-2007: During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician

Source page: https://510kreport.com/device/P970003
Methodology: https://510kreport.com/methodology