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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:108418

Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.

Official recall number

Z-0894-2013

Evidence summary

Product code
MHY
Recall status
Terminated
Event initiated
March 28, 2012
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0894-2013