Boston Scientific recalls Imager II angiographic catheters over tip detachment risk

Boston Scientific has issued a recall of its Imager II Angiographic Catheters after a manufacturing problem that can cause the catheter tip to detach during use.

The FDA classified the recall as the most serious type, warning that continued use could cause serious injury or death. On August 24 the company sent a letter telling customers to stop using and distributing the devices, to segregate the affected inventory, and to continue standard care for patients already treated.

Facilities are asked to check both inner and outer packaging UPN codes when searching for the catheters and to complete the enclosed Reply Verification Tracking Form to confirm removal.