Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT

Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.

On 6/17/2026, removal notices were mailed and emailed to customers informing them of the following: 1) Stop further use or distribution and segregate affected product. 2) Complete and return the Reply Verification Tracking Form via email to BSCFieldActionCenter@bsci.com 3) Return affected devices to firm. 4) Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which these systems may have been transferred. Report any adverse events or quality concerns associated with use of these devices to firm via email at BSCComplaints@bsci.com This removal of unused Infinion CX Leads is part of the planned transition to the next generation lead (Infinion Pro).

• FDA enforcement recordOfficial FDA database entry for Z-2879-2026
• FDA device classification · LGWOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Boston Scientific Neuromodulation CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.