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Health Canada Medical devices

Vercise Genus™ R 16 and R32 Implantable Pulse Generator Kits

Issued July 18, 2025
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
Hazard description
Performance
Product
Product name
Vercise Genus™ R 16 and R32 Implantable Pulse Generator Kits
Reference
ID
RA-77751