Reported Apr 1, 2020 · Ongoing
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
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?
VNS Therapy ProgrammerModel 3000 used with Models 103104105106or 8103 VNS Therapy generators
- Lot codes and dates
- Model 3000 version 1.6
- Amount recalled
- 2683
Where it was sold
Why it was recalled
False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.
This product could cause temporary or reversible health problems — stop using it.
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