Health Canada — Medical Devices · Canada · 2026-09-04 · Type II
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Reported risk: Boston Scientific is initiating removal of Imager II Angiographic Catheters (“Catheters”) due to a manufacturing issue affecting the catheter tip. This removal affects the devices identified in Attachment 1 of the customer letter. Boston Scientific has determined that these Catheters were manufactured with reduced levels of stabilizing agents in the tips. This may increase the risk of tip degradation and detachment.
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