Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Advanced Neuromodulation Systems Recalled by Advanced Neuromodulation Systems Inc. Due to Unintended Fluid ingress into the device header has...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Neuromodulation Systems Inc. directly.
Affected Products
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Quantity: 388 units
Why Was This Recalled?
Unintended Fluid ingress into the device header has been shown.
Where Was This Sold?
Worldwide Distribution - 53 consignees out of the US.
About Advanced Neuromodulation Systems Inc.
Advanced Neuromodulation Systems Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report