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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:210298

SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).

Official recall number

Z-1073-2025

Evidence summary

Product code
LYJ
Recall status
Open, Classified
Event initiated
December 12, 2024
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1073-2025