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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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- SevereAdvanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Devices
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