Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion Cx Lead

Boston Scientific is recalling the Infinion CX Lead, a spinal cord stimulator device, because the lead body may crack or break at the anchor site, which can stop the device from working properly and require surgical removal and replacement. This affects patients who have received this specific lead as part of their spinal cord stimulator system. The issue stems from mechanical stress on the lead at the point where it's anchored in place.

Recalling firm

Spinal Cord Stimulator

Reason

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

Category

drug recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-09-03

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/a1779918-83c7-4c3b-850a-b57df7d40f2b