Boston Scientific Infinion CX Lead Kit
Boston Scientific recalls Infinion CX lead kits for SCS systems due to possible lead fracture at anchor site.
Contact Boston Scientific Neuromodulation Corporation or your healthcare provider to determine if your lead kit is affected and to discuss next steps, which may include lead explant and replacement.
Why it was recalled
Boston Scientific Neuromodulation Corporation is recalling Infinion CX Lead Kits used with its Spinal Cord Stimulator (SCS) systems because the lead body may be exposed to stress at the anchor site, potentially causing high impedance measurements or lead fractures. This can result in inadequate stimulation and may require additional intervention, including lead explant and replacement.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Model |
|---|---|
| INFINION CX LEAD KIT, 50CM | SC-2317-50 |
| INFINION CX LEAD KIT, 70CM | SC-2317-70 |
Where it was sold
Distributed in New York.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Boston Scientific Neuromodulation Corporation
All recalls from Boston Scientific Neuromodulation Corporation
Editorial summary by Recall Canary · summary updated 2026-08-06 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification