SeriousFDAOngoing
Can cause serious illness or death. Do not eat it.
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.
Check your package for
Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
- Why
- 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.
- Distributed
- 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
- Company
- Boston Scientific Neuromodulation Corporation
- Announced
- Recall began