medical HIGH RISK Updated 2026-08-12

Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M36

See all recalls from Boston Scientific Neuromodulation Corporation →

Recalled 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.

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Hazard / Issue

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.

Issued by

FDA

Affected States: NY
Lot/Code Info: Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for INFINION CX LEAD KIT, →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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