Reported Dec 16, 2020 · Terminated
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in…
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 SENTIVA DUO # 1000-D -
- Product Usageindicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode
- Lot codes and dates
- Model
- Number - Model 1000-D Serial Numbers
311298310443310068310353310531310351310380310348
- Amount recalled
- 8 generators
Why it was recalled
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
This product could cause temporary or reversible health problems — stop using it.
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