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Health Canada Medical devices

SureTek™ Burr Hole Cover

Issued July 18, 2025
Issue
Boston Scientific is initiating a product correction (IFU update) to address difficulties while locking SureTek™ Burr Hole Covers (BHC) to secure deep brain stimulation (DBS) leads, part of the Vercise™ Deep Brain Stimulation System. In some cases, resistance has been encountered while closing the retaining clip locking mechanism to securely hold the lead in place. Recall start date: July 8, 2025
Hazard description
Performance
Product
Product name
SureTek™ Burr Hole Cover
Reference
ID
RA-77745