Reported Feb 12, 2025 · Ongoing
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve…
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?
- SenTiva
- REF1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS)
- Lot codes and dates
- UDI-DI05425025750405. All Serial Numbers less than 500,000
- Amount recalled
- 48
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
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.
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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