Vagus Nerve Stimulation Therapy Alerts This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

LivaNova USA, Inc. - PerenniaDURA VNS Therapy Leads - Class 2 Recall
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter) (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2022 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - VNS Therapy M1000D SenTiva Generator - Class 2 Recall
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 5, 2020 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - VNS Therapy AspireSR Generator - Class 2 Recall
VNS Therapy¿ AspireSR¿ Generator (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2020 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - VNS Therapy Programmer - Class 2 Recall
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2020 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - VNS Therapy SenTiva Generator Model 1000 - Class 2 Recall
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 11, 2020 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - Cyberonics VNS Therapy AspireHC Model 105 Generator - Class 2 Recall
Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2020 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - Cyberonics VNS Therapy AspireSR, Model 106 Generator - Class 2 Recall
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2020 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - VNS Therapy SenTiva Generator, Model 1000 - Class 1 Recall
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2019 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - Vagus Nerve Stimulation Therapy System - Class 2 Recall
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 11, 2019 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - VNS Therapy, Sentiva, - Class 2 Recall
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Progra...
Source: Medical Device Recalls - November 8, 2019 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - VNS Therapy Programming System - Class 2 Recall
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 29, 2018 Category: Medical Devices Source Type: alerts

Cyberonics, Inc - VNS Therapy Programmer, Model 3000 v1.0 System - Class 2 Recall
VNS Therapy Programmer, Model 3000, v1.0 System (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2018 Category: Medical Devices Source Type: alerts

Cyberonics, Inc - VNS(R) Therapy Programmer - Class 2 Recall
VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressan...
Source: Medical Device Recalls - February 8, 2018 Category: Medical Devices Source Type: alerts

Cyberonics, Inc - Model 106 AspireSR Generators - Class 2 Recall
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and ha...
Source: Medical Device Recalls - August 12, 2017 Category: Medical Devices Source Type: alerts

Cyberonics, Inc - Model 105 Aspire HC and Generators - Class 2 Recall
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and ha...
Source: Medical Device Recalls - August 12, 2017 Category: Medical Devices Source Type: alerts