FDA recall, , High risk
Boston Scientific Infinion CX Lead Kit
The INFINION CX lead kit may have stress at the anchor site, causing high impedance or lead fractures.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Neuromodulation Corporation, of Valencia, California, recalled INFINION CX lead kits, part of its Spinal Cord Stimulator (SCS) Systems, on June 17, 2026. The lead body may be exposed to stress at the anchor site, which may result in high impedance measurements or lead fractures, leading to inadequate stimulation and additional intervention, including lead explant and replacement.
The FDA added the recall to its Enforcement Report on August 5, 2026. The kits were distributed in New York and in Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, and Argentina.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
Infinion CX Lead Kit, 50CM
- Model
- SC-2317-50
- UDI-DI
- 08714729861614
- 08714729861638
Infinion CX Lead Kit, 70CM
- Model
- SC-2317-70
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
US: New York. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina
- Company
- Boston Scientific Neuromodulation CorporationValencia, California
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98974
- Recall number
- Z-2879-2026
All recalls from Boston Scientific Neuromodulation Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
