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FDA Safety Alert

Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead

U.S. Food and Drug Administration
September 3, 2026
ID: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/spinal-cord-stimulator-recall-boston-scientific-removes-infinion-cx-lead

FDA MedWatch Safety Alert

Infinion CX Lead bodies may experience mechanical stress at the anchor site resulting in inadequate stimulation requiring lead explant and replacement.

Content syndicated from the official FDA MedWatch Safety Alerts and Adverse Event Reporting Program.

View Official Announcement on FDA.gov