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: M365SC231
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- 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
- Recall initiated
- 2026-06-17
- Code info
- Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
- Product quantity
- 1079
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Valencia
- State
- CA
- Country
- United States
- Event id
- 98974
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