Recall MonitorHealth Products
SureTek™ Burr Hole Cover
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: SureTek™ Burr Hole Cover
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 |
|---|---|---|
| Burr Hole Cover Kit | Not applicable. | DB-4600-C |
| Burr Hole Cover Kit | Not applicable. | DB-4605-C |
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