Vercise Genus™ R 16 and R32 Implantable Pulse Generator Kits
Last updated
Summary
Product
Vercise Genus™ R 16 and R32 Implantable Pulse Generator Kits
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop, Valencia, California, United States, 91355
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77751
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