Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT
- Recalling company
- Boston Scientific Neuromodulation Corporation
- 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.
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Jun 17, 2026
- Reported
- Aug 12, 2026
- 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
- Status
- Ongoing
- Quantity
- 1079
- Lot / codes
- Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
- Company location
- Valencia, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2879-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2879-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.