Official recall record
Carotid Wallstent™ Monorail
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-07-11
- Country of alert
- Canada
- Alert level
- Type I
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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