Official recall record
VARIPULSE™ Bi-Directional Ablation Catheter
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-02-25
- Country of alert
- Canada
- Alert level
- Type I
- Alert type
- recall
What the authority reported
Biosense Webster, Inc. is contacting users of the VARIPULSE™ Bi-Directional Ablation Catheter to inform that it has initiated a field safety notice and share updates to the Instructions for Use (IFU) for the VARIPULSE™ Bi-Directional Ablation Catheters as a result of neurovascular events that were reported in the US. These updates to the existing labeling include important updates on the device's risks. Recall start date: February 21, 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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