SureTek™ Burr Hole Cover
Last updated
Summary
Product
SureTek™ Burr Hole Cover
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop, Valencia, California, United States, 91355
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77745
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