Reported Mar 6, 2013 · Terminated
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable…
Advanced Neuromodulation Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Neuromodulation Systems Inc. · 6901 Preston Rd · Plano, TX · 75024-2508
Is this the product you have?
- Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
- Lot codes and dates
- Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.
- Amount recalled
- 388 units
Why it was recalled
Unintended Fluid ingress into the device header has been shown.
This product could cause temporary or reversible health problems — stop using it.
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