Reported Aug 12, 2026 · Ongoing · Updated Sep 16, 2026
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70,…
Boston Scientific Neuromodulation Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Neuromodulation Corporation · 25155 Rye Canyon Loop · Valencia, CA · 91355-5004
Is this the product you have?
- INFINION CX LEAD KIT, 50CM
- ModelSC-2317-50
- Material
M365SC2317500INFINION CX LEAD KIT70CM
- ModelSC-2317-70
- MaterialM365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems
- Lot codes and dates
- Model/UDI-DISC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products
- Amount recalled
- 1079
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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