Use cautionMedical device recall · FDA · Published June 17, 2026
Boston Scientific INFINION CX Lead Kits Recall: Risk of Lead Fractures
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 INFINION CX Lead Kits Recall: Risk of Lead Fractures.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314336-boston-scientific-infinion-cx-lead-kits-recall-risk-of-lead. Based on FDA recall #Z-2879-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2879-2026%22&limit=1).
The FDA announced on June 17, 2026, that Boston Scientific Neuromodulation Corporation is voluntarily recalling INFINION CX LEAD KIT models SC-2317-50 and SC-2317-70. The lead bodies may be exposed to stress at the anchor site, potentially causing fractures or inadequate stimulation.
How to tell if you have it
Brand: Boston Scientific
Product: INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500
Product: INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700
Model/UDI-DI: SC-2317-50/08714729861614
Model/UDI-DI: SC-2317-70/08714729861638
Units affected: 1079
The hazard
The 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.
Context
Boston Scientific Neuromodulation Corporation has 12 other recalls on record since April 24, 2019. Recent actions include the April 29, 2026 SC-4318 Clik X Anchor Recall for lack of sterility assurance and the CSK Electrodes Recall for performance issues. Other recent recalls of similar products include the Inspire Stimulation Lead Recall (May 11, 2026) and the Magellan LeadCare II Blood Lead Test Kits recall (March 13, 2026).
How to tell if you have this one
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.
Brand
Boston Scientific
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Boston Scientific
Reach out to Boston Scientific for repair or replacement options for the recalled lead kits.
Where it went and when
Where it was distributed
Distributed in New York, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2879-2026 (June 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2879-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.