VARIPULSE™ Bi-Directional Ablation Catheter
Brand(s)
Last updated
Summary
Product
VARIPULSE™ Bi-Directional Ablation Catheter
Issue
Medical devices - Labelling and packaging
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 |
|---|---|---|
| VARIPULSE Bi-Directional Ablation Catheter | All lots. | D141201 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
| Biosense Webster, Inc. |
| 31 Technology Drive, Irvine, California, United States, 92618 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-77016
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