Boston Scientific recalls spinal cord stimulator leads after over 1,000 serious injuries

Boston Scientific announced a recall of its Infinion CX spinal cord stimulation leads after the FDA classified the action as the most serious level.

The recall, issued June 17, covers all unused leads of models SC-2317-50 and SC-2317-70, which are 50 cm and 70 cm in length, because they may break.

Boston Scientific reported 1,081 serious injuries linked to the device as of May 27, but no deaths, and the recall does not affect leads already implanted.

The company recently also halted sales of its Imager II angiographic catheters after an FDA alert about tip manufacturing issues.