Official recall notice
FDA DeviceClass INotable
FDA Recall: INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM
- Recall date
- 2026-08-12
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
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.
Product description
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
Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.