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Advanced Neuromodulation Systems Inc. recalls Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pul
Recalled March 6, 2013 · FDA recall Z-0894-2013 · Advanced Neuromodulation Systems
Hazard
Unintended Fluid ingress into the device header has been shown. · FDA Class II
Units
388 units
Sold at
Worldwide Distribution - 53 consignees out of the US.
Description
Unintended Fluid ingress into the device header has been shown.
Product
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Manufacturer(s)
Advanced Neuromodulation Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →