- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
- Units affected
- 1079
- Distribution pattern
- 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
- Firm location
- Valencia, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2879-2026
- Recall initiated
- June 17, 2026
- FDA classification date
- August 5, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 98974
- Last updated on HTM Vibe
- August 18, 2026