Recall MonitorHealth ProductsType I recall
Carotid Wallstent™ Monorail
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Carotid Wallstent™ Monorail
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Carotid Wallstent™ Monorail | More than 10 numbers, contact manufacturer. | H965SCH647090 |
| Carotid Wallstent™ Monorail | More than 10 numbers, contact manufacturer. | H965SCH647130 |
| Carotid Wallstent™ Monorail | More than 10 numbers, contact manufacturer. | H965SCH647010 |
| Carotid Wallstent™ Monorail | More than 10 numbers, contact manufacturer. | H965SCH647070 |
| Carotid Wallstent™ Monorail | More than 10 numbers, contact manufacturer. | H965SCH647120 |
| Carotid Wallstent™ Monorail | More than 10 numbers, contact manufacturer. | H965SCH647140 |
| Carotid Wallstent™ Monorail | More than 10 numbers, contact manufacturer. | H965SCH647080 |
Issue
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