Recall MonitorHealth Products
Vercise Genus™ R 16 and R32 Implantable Pulse Generator Kits
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Neurology
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
Recall class: Type II
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