Boston Scientific recalls over 262,000 Imager II catheters globally

Boston Scientific has initiated a global voluntary recall of 262,686 Imager II angiographic catheters due to a risk of the device tip fracturing or detaching during use. The defect could cause fragments to remain within a patient's body or migrate through the vascular system, potentially leading to embolisms that may be life-threatening or requiring prolonged medical procedures.

The recall, classified as Class I, was voluntarily started by the manufacturer on August 24, 2026. The affected products are used as flexible tubes to inject contrast agents for visualizing blood vessels during imaging exams. The scope of the recall is international, affecting markets including Morocco, the United States, various European countries, the Middle East, Asia, Africa, and Latin America.