INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, M

FDA device recall Z-2879-2026 · posted 2026-08-05 · Open, Classified

Recall details

Recalling firm

Boston Scientific Neuromodulation Corporation

Reason for recall

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.

Action taken

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).

Root cause

Device Design

Status

Open, Classified

Product code

LGW

Quantity affected

1079

Distribution

US: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina

Date initiated

2026-06-17

Date posted

2026-08-05

Location

Valencia, CA