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# Boston Scientific Recalls Spinal Cord Stimulator Leads
- URL: https://www.fdaweb.com/boston-scientific-recalls-spinal-cord-stimulator-leads/
- Published: 2026-09-03T12:00:00.000Z
- Updated: 2026-09-14T12:05:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161731

Boston Scientific has recalled (Class 1) all unused spinal cord stimulator Infinion CX Leads after determining that the 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,” an FDA [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/spinal-cord-stimulator-recall-boston-scientific-removes-infinion-cx-lead?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. As of 5/27, Boston Scientific has reported 1,081 serious injuries and no deaths associated with the issue.

The leads are a component of the spinal cord stimulator, which is used in managing chronic back or limb pain.