Boston Scientific recalls Infinion CX spinal cord stimulator leads over risk of mechanical stress and fracture

Boston Scientific issued a recall of its Infinion CX spinal cord stimulator leads after identifying a risk of mechanical stress at the anchor site that can cause high impedance readings or lead fractures.

The company instructed customers to stop using and distributing any unused leads, to segregate them, and to return them to Boston Scientific. No extra patient monitoring beyond routine follow-up is required for devices already implanted.

The recall includes 50 cm and 70 cm lead kits (models SC-2317-50M and SC-2317-70M). The FDA classified the recall as the most serious type because continued use could lead to serious injury or death.