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Vercise genus™ r 16 and r32 implantable pulse generator kits

Official notice

18 Jul 2025

MediumHealth Canada

An official Health Canada notice concerns Vercise genus™ r 16 and r32 implantable pulse generator kits. In August 2024, Boston Scientific reminded deep brain stimulation (DBS) customers to follow the steps outlined in the labeling/ifu (instructions for use) to implant Vercise DBS Implantable Pulse Generators (IPGs) within a subcutaneous pocket. Boston Scientific is now providing an update to the previous communication. An IFU revision is being implemented to include an additional warning statement. Recall start date: July 8, 2025 Published 2025-07-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77751

Official notice

2025-07-18

The hazard

In August 2024, Boston Scientific reminded deep brain stimulation (DBS) customers to follow the steps outlined in the labeling/ifu (instructions for use) to implant Vercise DBS Implantable Pulse Generators (IPGs) within a subcutaneous pocket. Boston Scientific is now providing an update to the previous communication. An IFU revision is being implemented to include an additional warning statement. Recall start date: July 8, 2025

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.

Recall Numbers

77751

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Affected products

Product 1

Affected products - Vercise Genus™ R32 Implantable Pulse Generator Kit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DB-1232

Product 2

Affected products - Vercise Genus™ R16 Implantable Pulse Generator Kit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DB-1216

Risk / hazard

In August 2024, Boston Scientific reminded deep brain stimulation (DBS) customers to follow the steps outlined in the labeling/ifu (instructions for use) to implant Vercise DBS Implantable Pulse Generators (IPGs) within a subcutaneous pocket. Boston Scientific is now providing an update to the previous communication. An IFU revision is being implemented to include an additional warning statement. Recall start date: July 8, 2025

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Boston Scientific Neuromodulation, Vercise Genus™ R 16 And R32 Implantable Pulse Generator Kits.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77751

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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