Recall Z-2879-2026— Boston Scientific Neuromodulation Corporation
Class I · Ongoing
Class I FDA medical device recall by Boston Scientific Neuromodulation Corporation, initiated 2026-06-17. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-06-17
- Firm location
- Valencia, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.