Reported Feb 5, 2025 · Ongoing
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA…
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"
- Product NameVNS Therapy" SenTiva"
- Model 1000 Model/Catalog Number1000
- 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 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210
- ComponentThe LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS)
- Lot codes and dates
- Lot CodeModel
- No 1000 UDI-DI05425025750405
- Lot Numbers/Serial Numbers
4,710 of 4,710 codes
215172151821519021520021521021522021530215312153221533215342153521536215380215400215412154221543215442154521546215472154821550215512155321554215552155621558215592156021562215632156402156702156802156921570215712157321575215770215802158102158202158321584021585215862158921590021591215932159402159502159721598215990216000
- Amount recalled
- 8223 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new LivaNova USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.