Carotid Wallstent™ Monorail
Brand(s)
Last updated
Summary
Product
Carotid Wallstent™ Monorail
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
| Boston Scientific Corporation |
| 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-77725
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