PMA · Approved
Recalled · Class I · 2025VNS Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LivaNova USA, Inc. · LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Approved on Jul 16, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 170-day review. It has a Class I recall. It has been recalled 30 times, including a Class I recall.
- Decided
- Jul 16, 1997
- Review
- 170 days
- Class
- Class III
- Product code
- LYJ
- Recalls
- 30 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P970003 has 238 supplements since 1997: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
1997high 26 (2011) · low 1 (2021)2026
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1997 | 4 |
| 1998 | 7 |
| 1999 | 10 |
| 2000 | 3 |
| 2001 | 6 |
| 2002 | 6 |
| 2003 | 6 |
| 2004 | 3 |
| 2005 | 7 |
| 2006 | 10 |
| 2007 | 21 |
| 2008 | 9 |
| 2009 | 3 |
| 2010 | 10 |
| 2011 | 26 |
| 2012 | 10 |
| 2013 | 13 |
| 2014 | 6 |
| 2015 | 14 |
| 2016 | 18 |
| 2017 | 9 |
| 2018 | 3 |
| 2019 | 7 |
| 2020 | 6 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 3 |
| 2025 | 6 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2025 | Class II | Z-1068-2025 | Device Design | 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 | Device Design | 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 | Device Design | 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 returning to baseline seizure frequency or… |
| Dec 2, 2021 | Class II | Z-0532-2022 | Process change control | 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 experience discomfort or pain due to… |
| Sep 28, 2020 | Class II | Z-0462-2021 | Process control | 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 | Software Design Change | 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 instructed to lower output current and… |
| Aug 22, 2019 | Class I | Z-0561-2020 | Device Design | 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 may lead to additional surgery… |
| Aug 13, 2019 | Class II | Z-1118-2020 | Process control | 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 | Software design | 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 the lead impedance measurement during… |
| Nov 16, 2018 | Class II | Z-0663-2020 | Software design | 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 diagnostic test on Model 102 and Model 102R… |
| Nov 16, 2018 | Class II | Z-0869-2020 | Manufacturing material removal | 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… |
| Nov 16, 2018 | Class II | Z-0868-2020 | Manufacturing material removal | 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… |
| Jan 24, 2018 | Class II | Z-2572-2018 | Software design (manufacturing process) | 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 | Employee error | 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 | Device Design | 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 to: " Delivery of more stimulation than… |
| Dec 18, 2015 | Class II | Z-0659-2016 | Device Design | 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 is disabled. |
| Nov 18, 2015 | Class II | Z-0645-2016 | Manufacturing material removal | 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 | Manufacturing material removal | 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 | Labeling mix-ups | The recalled product was distributed with an incorrect serial number printed on the device's label. |
| Aug 12, 2011 | Not classified | Z-0210-2012 | Nonconforming Material/Component | 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 during stimulation. |
| May 6, 2011 | Not classified | Z-0005-2012 | Software design (manufacturing process) | 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 8.0 software to interrogate a… |
| May 6, 2011 | Not classified | Z-0006-2012 | Software design (manufacturing process) | 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 8.0 software to interrogate a… |
| Apr 6, 2010 | Not classified | Z-1591-2010 | Software design | Battery life projection is inaccurate. |
| Feb 7, 2008 | Not classified | Z-0994-2009 | Software design | 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 | Software design | 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 | Process control | Dissolution/Fractures to the leads of the VNS Therapy System |
| Aug 2, 2007 | Not classified | Z-0172-2008 | Process control | Dissolution/Fractures to the leads of the VNS Therapy System |
| Aug 2, 2007 | Not classified | Z-0173-2008 | Process control | Dissolution/Fractures to the leads of the VNS Therapy System |
| Oct 17, 2006 | Not classified | Z-0342-2007 | Other | 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 | Other | During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician |
The 5 latest of 30 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LYJ devicesLYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYJ
6in 2025
2007high 24 (2011) · low 0 (2012)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LYJ
Too few LYJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LYJ
2in 2025
2007high 4 (2007) · low 0 (2012)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LYJ
1,426in 2025
2007high 3,809 (2013) · low 1,426 (2025)2025
MAUDE reports naming product code LYJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | — | 4 | 1,889 |
| 2008 | 9 | — | 2 | 2,758 |
| 2009 | 3 | — | 2 | 2,688 |
| 2010 | 10 | — | 1 | 2,749 |
| 2011 | 24 | — | 3 | 3,042 |
| 2012 | 0 | — | 0 | 3,364 |
| 2013 | 0 | — | 0 | 3,809 |
| 2014 | 0 | — | 1 | 3,365 |
| 2015 | 2 | — | 3 | 3,265 |
| 2016 | 14 | — | 0 | 2,851 |
| 2017 | 9 | — | 1 | 2,074 |
| 2018 | 3 | — | 4 | 2,316 |
| 2019 | 7 | — | 1 (1) | 2,432 |
| 2020 | 6 | — | 2 | 1,688 |
| 2021 | 1 | — | 1 | 1,764 |
| 2022 | 3 | — | 0 | 1,584 |
| 2023 | 5 | — | 0 | 1,764 |
| 2024 | 3 | — | 0 | 1,524 |
| 2025 | 6 | — | 2 | 1,426 |
| 2026 | 3 | — | 0 | — |
https://510kreport.com/device/P970003 · printed Nov 6, 2026
Cite this page
510(k) Report. “P970003: VNS Therapy System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P970003
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026