Recall Z-1073-2025— LivaNova USA, Inc.
Class II · Ongoing
Class II FDA medical device recall by LivaNova USA, Inc., initiated 2024-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).. Reason: Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device..
- Recalling firm
- LivaNova USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-12
- Firm location
- Houston, TX, United States
Product description
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Reason for recall
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.