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The official notice did not include a photo. Check the product details and identifiers below.
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Suretek™ burr hole cover
Official notice
18 Jul 2025
An official Health Canada notice concerns Suretek™ burr hole cover. 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 Published 2025-07-18.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77745
Official notice
2025-07-18
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Affected area 1
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Company & contacts
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Phone
Brand: Boston Scientific Neuromodulation, Suretek™ Burr Hole Cover.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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