The Recall Desk
SevereFDA (Devices)·Z-2879-2026·Announced 2026-08-12

Boston Scientific Spinal Cord Stimulator Lead Kits Recalled

Boston Scientific is recalling INFINION CX LEAD KITs (50cm and 70cm) used in spinal cord stimulator systems due to potential lead body stress at the anchor site, which may cause lead fractures or high impedance and result in inadequate stimulation or need for additional surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which per the rubric criteria warrants a severity score of at least 4 (Severe). The device malfunction may lead to inadequate stimulation and additional surgical interventions including lead explant and replacement.

Plain-English summary

Boston Scientific Neuromodulation Corporation is recalling INFINION CX LEAD KITs, Models SC-2317-50 and SC-2317-70, which are part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems. A total of 1,079 units are included in the recall.

The recall is due to a potential issue where the lead body may be exposed to stress at the anchor site. This stress may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

The affected products were distributed in New York in the US and internationally to Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, and Argentina. The recall includes all unused products.

Healthcare providers and patients with questions should contact Boston Scientific Neuromodulation Corporation. Patients experiencing issues with their spinal cord stimulator should consult their healthcare provider.

The recalled product

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.
Manufacturer
Boston Scientific Neuromodulation Corporation
Category
Medical Device — Spinal Cord Stimulator Leads
Hazard
Affected units
1,079

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model/UDI-DI: SC-2317-50/08714729861614
  • SC-2317-70/08714729861638. All unused products.

Distribution

Distributed in 1 state:

Related recalls

Same manufacturer · Boston Scientific Neuromodulation Corporation

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