Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA product code LYJ · Class III (high risk) · Neurology
0510(k) clearances
1PMA approvals
37recalls
Implantimplanted device
PMA approvals
- P970003 VNS Therapy System · LivaNova USA, Inc. · 07/16/1997
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1068-2025 Class II | Brand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model 1000-D…Their is a potential that implanted pulse generators may stop delivering therapy due to an internal… | LivaNova USA, Inc. | 01/03/2025Open, Classified |
| Z-1067-2025 Class II | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog…Their is a potential that implanted pulse generators may stop delivering therapy due to an internal… | LivaNova USA, Inc. | 01/03/2025Open, Classified |
| Z-1073-2025 Class II | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst…Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated… | LivaNova USA, Inc. | 12/12/2024Open, Classified |
| Z-1072-2025 Class II | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System.…Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated… | LivaNova USA, Inc. | 12/12/2024Open, Classified |
| Z-0532-2022 Class II | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20…A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be… | LivaNova USA, Inc. | 12/02/2021Terminated |
| Z-0535-2021 Class II | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic…During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model… | LivaNova USA Inc | 11/12/2020Terminated |
| Z-0462-2021 Class II | VNS Therapy AspireSR GeneratorDue to an extra digit being inadvertently added to the serial number of a subset of implantable pulse… | LivaNova USA Inc | 09/28/2020Terminated |
| Z-1563-2020 Class II | VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS…False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2)… | LivaNova USA Inc | 02/04/2020Open, Classified |
| Z-0561-2020 Class I | VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve…Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but… | LivaNova USA Inc | 08/22/2019Terminated |
| Z-1118-2020 Class II | VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator…Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which… | LivaNova USA Inc | 08/13/2019Terminated |
| Z-0869-2020 Class II | Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on…This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature… | LivaNova USA Inc | 11/16/2018Terminated |
| Z-0868-2020 Class II | Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on…This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature… | LivaNova USA Inc | 11/16/2018Terminated |
| Z-0663-2020 Class II | VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnlyThis recall is being initiated due to reports that that the therapy programming tablet with software version… | LivaNova USA Inc | 11/16/2018Open, Classified |
| Z-0346-2020 Class II | The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an…Lead impedance values reported by the affected VNS generator will be higher compared to those reported by… | LivaNova USA Inc | 11/16/2018Open, Classified |
| Z-2572-2018 Class II | VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. | LivaNova USA Inc | 01/24/2018Terminated |
| Z-0555-2018 Class II | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications:…Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software. | Cyberonics, Inc | 12/02/2017Terminated |
| Z-3020-2017 Class II | VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 106. Product…Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster… | Cyberonics, Inc | 06/13/2017Terminated |
| Z-3019-2017 Class II | VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. Product…Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster… | Cyberonics, Inc | 06/13/2017Terminated |
| Z-0659-2016 Class II | VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in…Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the… | Cyberonics, Inc | 12/18/2015Terminated |
| Z-0645-2016 Class II | Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat… | Cyberonics, Inc | 11/18/2015Terminated |
| Z-0280-2016 Class II | Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat… | Cyberonics, Inc | 10/07/2015Terminated |
| Z-1526-2015 Class II | VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model…The pulse generators have a lower battery longevity than specified in their design requirement as a result… | Cyberonics, Inc | 03/06/2015Terminated |
| Z-0858-2015 Class II | Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System…The recalled product was distributed with an incorrect serial number printed on the device's label. | Cyberonics, Inc | 11/20/2014Terminated |
| Z-0210-2012 | VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics…The devices are being recalled because the output current delivered to the vagus nerve is less than the… | Cyberonics, Inc | 08/12/2011Terminated |
| Z-0006-2012 | Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104…An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator… | Cyberonics, Inc | 05/06/2011Terminated |
| Z-0005-2012 | VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103…An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator… | Cyberonics, Inc | 05/06/2011Terminated |
| Z-1591-2010 | VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator…Battery life projection is inaccurate. | Cyberonics, Inc | 04/06/2010Terminated |
| Z-0642-2010 | VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator…Under certain conditions, product's battery life can be reduced. | Cyberonics, Inc | 11/20/2009Terminated |
| Z-0264-2010 | Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version…Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare… | Cyberonics, Inc | 07/24/2009Terminated |
| Z-0995-2009 | Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable…Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet… | Cyberonics, Inc | 02/07/2008Terminated |
| Z-0994-2009 | Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable…Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet… | Cyberonics, Inc | 02/07/2008Terminated |
| Z-0568-2008 | Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5…Screen Freezes-- The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the… | Cyberonics, Inc | 10/25/2007Terminated |
| Z-0173-2008 | Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed…Dissolution/Fractures to the leads of the VNS Therapy System | Cyberonics, Inc | 08/02/2007Terminated |
| Z-0172-2008 | Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed…Dissolution/Fractures to the leads of the VNS Therapy System | Cyberonics, Inc | 08/02/2007Terminated |
| Z-0171-2008 | Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile…Dissolution/Fractures to the leads of the VNS Therapy System | Cyberonics, Inc | 08/02/2007Terminated |
| Z-0342-2007 | Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with…During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range… | Cyberonics, Inc | 10/17/2006Terminated |
| Z-0341-2007 | Cyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1…During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range… | Cyberonics, Inc | 10/17/2006Terminated |