Recall Monitor
Health ProductsType I recall

VARIPULSE™ Bi-Directional Ablation Catheter

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
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
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalogue number
VARIPULSE Bi-Directional Ablation CatheterAll 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

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