FDA Medical devices recall ·
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2879-2026
- Date
- (initiated June 17, 2026)
- Company / brand
- Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop, Valencia, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1079
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
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: New York
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2879-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.