SureTek™ Burr Hole Cover
Summary
Contact the manufacturer if you require additional information.
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
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop, Valencia, California, United States, 91355
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