FDA recall Z-0535-2021

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 for recall

During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.

Distribution

International distribution in the countries of Austria and United Kingdom.

Key facts

Status

Terminated

Initiation date

2020-11-12

Report date

2020-12-16

Termination date

2023-01-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2021