Z-2879-2026 Class I Ongoing
FDA device recall Z-2879-2026 was initiated by Boston Scientific Neuromodulation Corporation on June 17, 2026 and is designated Class I. 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, additi… The recall status is ongoing. Affected quantity: 1079.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- June 17, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1079
Product Description
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 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.
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
Code Information
Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.