Reported Feb 5, 2025 · Ongoing
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software…
LivaNova USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LivaNova USA, Inc. · 100 Cyberonics Blvd · Houston, TX · 77058-2069
Is this the product you have?
- Brand NameSenTiva DUO"
- Product NameVNS Therapy¿ SenTiva DUO"
- Model 1000-D Model/Catalog Number1000-D
- Software VersionNA
- Product DescriptionThe 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
- ComponentThe LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS)
- Lot codes and dates
- Lot CodeModel
- No 1000-D UDI-DI05425025750528
- Lot Numbers/Serial Numbers
84 of 84 codes
324841324842324843324844324845324846324847324848324849324850324851332681332682332684332685332686332687332688332689332692332693332695332696332697332699332700332701332702332704332705332706332707332708332709332710332811332812332813332814332815332820332823332826332827332829332830332831332833339950340073340106340108340110340111340112340113340114340115340116340117
- Amount recalled
- 84 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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