Boston Scientific recalls INFINION CX lead kits (50cm and 70cm models) due to potential lead fractures causing inadequate spinal stimulation. Affected users should contact for repair or replacement.
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.
Boston Scientific is recalling two models of spinal cord stimulation lead kits. The leads may fracture at the anchor site, leading to ineffective treatment or surgery to fix the problem.
The lead body in the spinal cord stimulation system may experience stress at the anchor point. This can cause high impedance readings or lead fractures, which might result in the device not working properly or requiring surgery to replace the lead.
Patients using Boston Scientific's Spinal Cord Stimulator (SCS) systems with the recalled lead kits are most at risk. The recall applies to unused products purchased between specific dates.
Check for the model numbers SC-2317-50 or SC-2317-70 on the lead kits. These are part of Boston Scientific's Spinal Cord Stimulator systems and were sold as unused products.
Reach out to Boston Scientific for repair or replacement options for the recalled lead kits.
The recalled models are INFINION CX Lead Kits, 50cm (Model: SC-2317-50) and 70cm (Model: SC-2317-70).
The lead body may be exposed to stress at the anchor site, which can cause fractures and lead to inadequate stimulation or surgery.
No, but you should contact Boston Scientific for repair or replacement as the recall requires action.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2879-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2879-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
