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Health Canada Medical devices

HURRICANE RX BILIARY BALLOON DILATATION CATHETER

Issued November 5, 2021
Issue
Boston Scientific Corporation (BSC) is initiating a removal of specific lots/batches of Hurricane RX Biliary balloon dilatation catheters in response to an increase in complaints reported for Pinholes in the balloon. The user may notice that the balloon either rapidly loses pressure or fails to gain or maintain pressure. To date, there have been no serious patient injuries reported. Recall date: 2021-10-21
Hazard description
Performance
Product
Product name
HURRICANE RX BILIARY BALLOON DILATATION CATHETER
Reference
ID
RA-63553