# Major Recall Alert: Vercise Genus™ R16 and R32 Implantable Pulse Generator Kits Recalled After IFU Revision Update
In a recent notification, **Boston Scientific** has announced a significant update regarding the Vercise Genus™ R16 and Vercise Genus™ R32 Implantable Pulse Generator Kits. This crucial recall impacts individuals relying on deep brain stimulation (DBS), emphasizing the importance of strictly adhering to the product's **Instructions for Use (IFU)** for safe implantation. Effective **July 8, 2025**, customers and healthcare providers are being urged to note an updated warning statement in the IFU associated with the product.
**Key Products Affected**:
- Vercise Genus™ R16 Implantable Pulse Generator Kit
- Vercise Genus™ R32 Implantable Pulse Generator Kit
Understanding the reasons and implications of this recall is essential for patient safety and proper product use.
## Why This Recall is Important
The **revised IFU warning** brings critical updates to ensure the safe and effective implantation of these DBS devices. Incorrect usage of the Vercise Genus™ Implantable Pulse Generators can lead to complications, especially if the devices are not placed within the recommended **subcutaneous pocket**. Boston Scientific's new precautions underscore the need to strictly comply with all guidelines to reduce risks during implantation.
Deep brain stimulation (DBS) therapies are life-changing for individuals managing conditions like Parkinson's disease, dystonia, or essential tremor. That’s why ensuring the correct application of these devices is a high priority for both manufacturers and healthcare professionals.
By revising the IFU, Boston Scientific aims to mitigate risks and improve patient outcomes. If your treatment plan includes one of these devices, staying informed about these updates is vital.
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## Details of the Recall
Here’s what we know so far:
- **Affected Product Models**:
- Vercise Genus™ R16 Implantable Pulse Generator Kit
- Vercise Genus™ R32 Implantable Pulse Generator Kit
- **Recall Reason**: An updated warning statement has been added to the product’s IFU to clarify procedures for creating a **subcutaneous pocket** during DBS device implantation.
- **Recall Start Date**: July 8, 2025
- **Manufacturer**: Boston Scientific
- **Region Impacted**: Canada
- **Official Announcement**: [Recall Notice from Canada](https://recalls-rappels.canada.ca/en/alert-recall/vercise-genustm-r-16-and-r32-implantable-pulse-generator-kits)
Boston Scientific initially issued a reminder in August 2024 about following IFU guidelines, and this updated warning further emphasizes a commitment to patient safety.
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## What You Should Do
If you or someone you know is using the Vercise Genus™ R16 or R32 Implantable Pulse Generator, it’s crucial to take the following steps:
1. **Check Your Device Information**: Confirm that your device is one of the affected models using the provided product details.
2. **Contact Your Healthcare Provider**: Discuss the recall update with your doctor or treatment team. They will ensure proper implantation techniques and address any concerns regarding device performance or safety.
3. **Follow the Updated IFU**: Adhere to all the revised guidelines in the updated IFU, which now includes a critical warning about subcutaneous pocket implantation.
4. **Stay Informed**: Visit [Canada’s Recall Alert Page](https://recalls-rappels.canada.ca/en/alert-recall/vercise-genustm-r-16-and-r32-implantable-pulse-generator-kits) for the latest updates.
Being proactive can help ensure your safety and prevent possible complications related to device misplacement during implantation.
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Boston Scientific’s recall of the Vercise Genus™ Implantable Pulse Generators underscores the importance of prioritizing patient safety and adhering to updated usage instructions. If you own or utilize one of these devices, take immediate action to review the updated IFU and consult your healthcare provider. Visit the official Canadian recall announcement [here](https://recalls-rappels.canada.ca/en/alert-recall/vercise-genustm-r-16-and-r32-implantable-pulse-generator-kits) for more details. Stay safe, informed, and protected.