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
⚠️ 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.
Is this relevant to me?
- Geography
- US, NY
- Source agency
- FDA
- Category
- Health
- Published
- June 17, 2026
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
What's affected?
- Product
- 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.
- Lot code
- Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
Additional details
Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 1079.
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