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Carotid wallstent™ monorail

Official notice

11 Jul 2025

HighHealth Canada

An official Health Canada notice concerns Carotid wallstent™ monorail. Boston Scientific is initiating the removal of certain batches of Carotid Wallstent™ Monorail endoprosthesis (carotid wallstent) devices due to an increase in complaints received in which physicians described encountering greater than anticipated resistance when attempting to withdraw/retract the Stent Delivery System (SDS) from the guidewire or Embolic Protection Device (EPD), after successful stent deployment. Recall start date: July 7, 2025 Published 2025-07-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77725

Official notice

2025-07-11

The hazard

Boston Scientific is initiating the removal of certain batches of Carotid Wallstent™ Monorail endoprosthesis (carotid wallstent) devices due to an increase in complaints received in which physicians described encountering greater than anticipated resistance when attempting to withdraw/retract the Stent Delivery System (SDS) from the guidewire or Embolic Protection Device (EPD), after successful stent deployment. Recall start date: July 7, 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

77725

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Affected products

Product 1

Affected products - Carotid Wallstent™ Monorail, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - H965SCH647090

Product 2

Affected products - Carotid Wallstent™ Monorail, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - H965SCH647130

Product 3

Affected products - Carotid Wallstent™ Monorail, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - H965SCH647010

Product 4

Affected products - Carotid Wallstent™ Monorail, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - H965SCH647070

Product 5

Affected products - Carotid Wallstent™ Monorail, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - H965SCH647120

Product 6

Affected products - Carotid Wallstent™ Monorail, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - H965SCH647140

Product 7

Affected products - Carotid Wallstent™ Monorail, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - H965SCH647080

Risk / hazard

Boston Scientific is initiating the removal of certain batches of Carotid Wallstent™ Monorail endoprosthesis (carotid wallstent) devices due to an increase in complaints received in which physicians described encountering greater than anticipated resistance when attempting to withdraw/retract the Stent Delivery System (SDS) from the guidewire or Embolic Protection Device (EPD), after successful stent deployment. Recall start date: July 7, 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, Carotid Wallstent™ Monorail.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

77725

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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