Recall Z-2879-2026 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Boston Scientific Neuromodulation Corporation
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.
| Date | Aug 5, 2026 (initiated Jun 17, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 BSCCo |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.