FDAFDA recall Z-2879-2026 · Aug 12, 2026
Boston Scientific Neuromodulation Corporation: INFINION CX LEAD KIT recall
Recall found
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.
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
- Quantity
- 1079
- 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
- Recalling firm
- Boston Scientific Neuromodulation Corporation, Valencia, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-17
Source: openFDA enforcement record Z-2879-2026 · search recall number Z-2879-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.