VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
Reported: December 16, 2020 Initiated: November 12, 2020 #Z-0535-2021
Product Description
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
Reason for Recall
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
Details
- Recalling Firm
- LivaNova USA Inc
- Units Affected
- 8 generators
- Distribution
- International distribution in the countries of Austria and United Kingdom.
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.. Recalled by LivaNova USA Inc. Units affected: 8 generators.
Why was this product recalled? ▼
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0535-2021.
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