Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: 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 Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000-D Generator was commercially approved for distribution in the U.S. on May 13, 2020 via PMA P970003/S231. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Code: Model No 1000-D UDI-DI: 05425025750528 Lot Numbers/Serial Numbers: 324841 324842 324843 324844 324845 324846 324847 324848 324849 324850 324851 332681 332682 332684 332685 332686 332687 332688 332689 332692 332693 332695 332696 332697 332699 332700 332701 332702 332704 332705 332706 332707 332708 332709 332710 332811 332812 332813 332814 332815 332820 332823 332826 332827 332829 332830 332831 332833 339950 340073 340106 340108 340110 340111 340112 340113 340114 340115 340116 340117 340118 340119 340120 340121 340122 340569 340570 340571 340572 340573 340574 340575 340576 340578 340579 340580 340581 340583 340584 340585 340586 340587 340588 340589
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- LivaNova USA, Inc.
- Reason for Recall:
- Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: 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 Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000-D Generator was commercially approved for distribution in the U.S. on May 13, 2020 via PMA P970003/S231. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).
Product Codes/Lot Numbers:
Lot Code: Model No 1000-D UDI-DI: 05425025750528 Lot Numbers/Serial Numbers: 324841 324842 324843 324844 324845 324846 324847 324848 324849 324850 324851 332681 332682 332684 332685 332686 332687 332688 332689 332692 332693 332695 332696 332697 332699 332700 332701 332702 332704 332705 332706 332707 332708 332709 332710 332811 332812 332813 332814 332815 332820 332823 332826 332827 332829 332830 332831 332833 339950 340073 340106 340108 340110 340111 340112 340113 340114 340115 340116 340117 340118 340119 340120 340121 340122 340569 340570 340571 340572 340573 340574 340575 340576 340578 340579 340580 340581 340583 340584 340585 340586 340587 340588 340589
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1068-2025
Related Recalls
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 depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
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 depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.