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Varipulse™ bi-directional ablation catheter
Official notice
25 Feb 2025
Last checked
25 Feb 2025
An official Health Canada notice concerns Varipulse™ bi-directional ablation catheter. 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 Published 2025-02-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77016
Official notice
2025-02-25
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
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Brand: Biosense Webster, Varipulse™ Bi-directional Ablation Catheter.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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