Brio DBS implantable pulse generators recalled for unintended fluid ingress
Advanced Neuromodulation Systems Inc. is recalling Brio DBS System Model 6788 implantable pulse generators because unintended fluid ingress into the device header has been shown.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source identifies an FDA Class II recall but does not report hospitalizations or injuries. Under the rubric, a risk-of-harm product without reported injury is High (3).
Plain-English summary
Advanced Neuromodulation Systems Inc. is recalling the Brio DBS System Model 6788 Implantable Pulse Generator, including IPG or R-IPG versions. The recall applies to all lots manufactured before March 16, 2012. The notice states that unintended fluid ingress into the device header has been shown.
The recall covers 388 units. Distribution is described as worldwide, with 53 consignees outside the United States.
The notice does not state what consumers or patients should do.
The recalled product
- Product
- Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
- Manufacturer
- Advanced Neuromodulation Systems Inc.
- Hazard
- Affected units
- 388
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Advanced Neuromodulation Systems Inc.
See all →- HighAdvanced Neuromodulation Systems Recalls Eon Mini Implantable Pulse Generators
FDA (Devices) · 2012-10-17
- SevereAdvanced Neuromodulation Systems Recalls Eon IPG for Heating Complaints
FDA (Devices) · 2012-09-05
- SevereAdvanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Systems
FDA (Devices) · 2012-09-05
- SevereAdvanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Devices
FDA (Devices) · 2012-07-18
Same hazard · fluid ingress
See all →- HighPyxis Medbank units recalled over fluid ingress causing smoke or fire
FDA (Devices) · 2025-11-05
- HighMedication dispensing stations recalled over fluid ingress causing smoke or fire
FDA (Devices) · 2025-11-05
- HighPyxis Pro MedStation units recalled over fluid ingress causing smoke or fire
FDA (Devices) · 2025-11-05
- HighControlled substance safe towers recalled over fluid ingress causing smoke or fire
FDA (Devices) · 2025-11-05
- HighPyxis Pro auxiliary drawers recalled over fluid ingress causing smoke or fire
FDA (Devices) · 2025-11-05