Medical device manufacturer Boston Scientific is pulling its spinal cord stimulators back after the devices have been linked to several injuries.
FDA
The FDA said Boston Scientific has issued a letter to affected customers recommending all unused Infinion CX Leads be removed from where they are used or sold. The agency said the action does not affect the devices that have already been implanted.
Boston Scientific said that the Spinal Cord Stimulator (SCS) System lead body may experience mechanical stress at the anchor site, which may result in high impedance measurements or lead fractures. Abnormal impedance measurement may lead to inadequate stimulation and/or additional intervention, including lead explant and replacement.
As of May 27, 2026, the company has reported 1,081 serious injuries and no deaths associated with this issue.
The Infinion CX Lead is a component of a Spinal Cord Stimulator System which is used in the management of chronic pain of the back of limbs.
