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Suretek™ burr hole cover

Official notice

18 Jul 2025

Last checked

18 Jul 2025

Critical riskHealth Canada
Watch Boston Scientific Neuromodulation

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

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

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

77745

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Affected products

Product 1

Affected products - Burr Hole Cover Kit, Lot or serial number - Not applicable., Model or catalog number - DB-4600-C

Product 2

Affected products - Burr Hole Cover Kit, Lot or serial number - Not applicable., Model or catalog number - DB-4605-C

Risk / 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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Boston Scientific Neuromodulation, Suretek™ Burr Hole Cover

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific Neuromodulation, Suretek™ Burr Hole Cover.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

77745

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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