Vercise Genus™ R 16 and R32 Implantable Pulse Generator Kits
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Vercise Genus™ R32 Implantable Pulse Generator Kit |
More than 10 numbers, contact manufacturer. |
DB-1232 |
Vercise Genus™ R16 Implantable Pulse Generator Kit |
More than 10 numbers, contact manufacturer. |
DB-1216 |
Issue
In August 2024, Boston Scientific reminded deep brain stimulation (DBS) customers to follow the steps outlined in the labeling/ifu (instructions for use) to implant Vercise DBS Implantable Pulse Generators (IPGs) within a subcutaneous pocket. Boston Scientific is now providing an update to the previous communication. An IFU revision is being implemented to include an additional warning statement.
Recall start date: July 8, 2025
Additional information
Details
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop, Valencia, California, United States, 91355
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