# Major Recall Alert: Burr Hole Cover Kit Recalled Due to Boston Scientific Product Correction
Boston Scientific has initiated a product correction regarding the SureTek™ Burr Hole Covers (BHC) that are part of the Vercise™ Deep Brain Stimulation System. The issue, which can lead to difficulties in locking the retaining clip mechanism used to secure deep brain stimulation (DBS) leads, prompted this corrective action to update the Instructions for Use (IFU). The recall officially began on **July 8, 2025**.
Deep brain stimulation is a critical procedure for individuals relying on advanced medical devices, making this update crucial to ensure patient safety. If you or someone you know is affected, read on for all the key details about this recall update, and learn the necessary steps you should take.
## Why This Recall is Important
The SureTek™ Burr Hole Cover Kit plays an essential role in securing DBS leads in place for patients undergoing therapy with Boston Scientific’s Vercise™ Deep Brain Stimulation System. However, difficulties have been reported when attempting to lock the retaining clip mechanism, potentially compromising the device's secure positioning.
When locking issues arise, it can lead to challenges in ensuring the effectiveness of the DBS system. The recall aims to mitigate these risks by improving the Instructions for Use (IFU) to provide better guidance on securely locking the Burr Hole Cover. Addressing this promptly is vital for maintaining the integrity of treatment and patient safety.
### Key reasons this recall matters:
- **Patient safety risks**: Improperly secured DBS leads could potentially lead to suboptimal outcomes for individuals relying on precise neurostimulation.
- **Product correction (IFU update)**: The revised instructions aim to provide medical professionals with comprehensive guidance on securing the Burr Hole Cover and addressing resistance issues when closing the retaining clip.
## Details of the Recall
Boston Scientific's recall impacts the SureTek™ Burr Hole Covers (BHC), which are part of the Vercise™ Deep Brain Stimulation System. Below are the essential details:
- **Category**: Deep Brain Stimulation System
- **Product**: Burr Hole Cover Kit
- **Brand**: Boston Scientific
- **Reason for Recall**: Difficulties locking the retaining clip mechanism to securely hold DBS leads in place.
- **Initiation Date**: July 8, 2025
- **Images of Affected Products**: [Click here to view the image](https://myrecalls.app/images/products/29337_1752935117.jpg)
- **Official Source**: For more information, visit the [Government of Canada recall page](https://recalls-rappels.canada.ca/en/alert-recall/suretektm-burr-hole-cover).
## What You Should Do
If you or your healthcare provider is using the SureTek™ Burr Hole Cover Kit, take the following steps:
1. **Check the product details**: Determine whether the affected product is part of your DBS setup.
2. **Contact Boston Scientific**: Medical professionals should contact Boston Scientific via the customer service channels provided in the official recall announcement for further instructions on the updated IFU.
3. **Follow updated guidelines**: Ensure that IFU guidance is followed explicitly to address locking mechanism resistance and secure the DBS leads effectively.
If you have questions, consult your healthcare provider or reach out to Boston Scientific's customer support for clarification.
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For more details on this recall, visit the [Government of Canada’s official recall announcement](https://recalls-rappels.canada.ca/en/alert-recall/suretektm-burr-hole-cover). Stay informed and stay safe!