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Health Canada Medical devices

Expo Angiographic Catheters

Issued April 3, 2024
Issue
Boston Scientific initiated a removal of certain batches of Expo 5F angiographic catheters due to an increase in complaints related to an inability to advance the guidewire through the lumen of the device. Our internal investigation has revealed that there is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining. Recall start date: March 21, 2024
Hazard description
Performance
Product
Product name
Expo Angiographic Catheters
Reference
ID
RA-75327