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Watchman™ access systems

Official notice

30 Jul 2025

HighHealth Canada

An official Health Canada notice concerns Watchman™ access systems. Boston Scientific is initiating an advisory to inform customers on the important information related to the risk of air embolism during WATCHMAN™ procedures. Product is not being recalled. Recall start date: July 29, 2025 Published 2025-07-30.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77788

Official notice

2025-07-30

The hazard

Boston Scientific is initiating an advisory to inform customers on the important information related to the risk of air embolism during WATCHMAN™ procedures. Product is not being recalled. Recall start date: July 29, 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

77788

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Affected products

Product 1

Affected products - WATCHMAN™ TruSeal™ Access System, Lot or serial number - Not applicable., Model or catalog number - M635TU70020

Product 2

Affected products - WATCHMAN™ TruSeal™ Access System, Lot or serial number - Not applicable., Model or catalog number - M635TU70010

Product 3

Affected products - WATCHMAN™ TruSeal™ Access System, Lot or serial number - Not applicable., Model or catalog number - M635TU70040

Product 4

Affected products - WATCHMAN FXD Curve™ Access System, Lot or serial number - Not applicable., Model or catalog number - M635TU80020

Product 5

Affected products - WATCHMAN FXD Curve™ Access System, Lot or serial number - Not applicable., Model or catalog number - M635TU80010

Product 6

Affected products - WATCHMAN TruSteer™ Access System, Lot or serial number - Not applicable., Model or catalog number - M635TU90050

Risk / hazard

Boston Scientific is initiating an advisory to inform customers on the important information related to the risk of air embolism during WATCHMAN™ procedures. Product is not being recalled. Recall start date: July 29, 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

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific, Watchman™ Access.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

77788

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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