Varipulse™ Bi-directional Ablation Catheter

Recall Summary The VARIPULSE™ Bi-Directional Ablation Catheter is being recalled in Canada due to labeling and packaging issues. This is a Class I recall, which means the product could cause serious harm or death. The affected catheters were distributed across Canada.

Product
VARIPULSE™ Bi-Directional Ablation Catheter
Reason
Labelling and packaging
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2025-02-25
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/8536370e-e453-4967-9ec8-e1859e60497f