Vercise Genus ™ R16 and R32 Implantable Pulse Generator (IPG) Kits
In plain language
This recall involves Vercise Genus™ R16 and R32 Implantable Pulse Generator (IPG) Kits sold in Canada. It's being recalled because of a performance issue that may prevent successful delivery of stimulation therapy. This recall is for healthcare professionals to ensure proper implantation procedures are followed.
What to do
- Contact the manufacturer if you require additional information.
- Follow the steps outlined in the labeling/instructions for use to implant the devices within a subcutaneous pocket.
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Affected products
Vercise Genus™ R32 Implantable Pulse Generator (IPG) Kit
Model: DB-1232
Lot: More than 10 numbers, contact manufacturer.
Vercise Genus™ R16 Implantable Pulse Generator (IPG) Kit
Model: DB-1216
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Performance issue
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: DB-1216, DB-1232
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issue
What should consumers do?
Contact the manufacturer if you require additional information. Follow the steps outlined in the labeling/instructions for use to implant the devices within a subcutaneous pocket.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issue
When was this product recalled?
This product was recalled on August 12, 2024.
Is the Boston Scientific Neuromodulation Corporation brand affected by this recall?
Yes, Boston Scientific Neuromodulation Corporation products are affected by this recall. This recall involves Vercise Genus™ R16 and R32 Implantable Pulse Generator (IPG) Kits sold in Canada. It's being recalled because of a performance issue that may prevent successful delivery of stimulation therapy. This recall is for healthcare professionals to ensure proper implantation procedures are followed.