Recall Z-0535-2021— LivaNova USA Inc
Class II · Terminated
Class II FDA medical device recall by LivaNova USA Inc, initiated 2020-11-12, terminated 2023-01-12. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated..
- Recalling firm
- LivaNova USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-12
- Terminated
- 2023-01-12
- Firm location
- Houston, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.