INFINION CX LEAD KIT, 50CM, Model recall
Boston Scientific Neuromodulation Corporation recalled INFINION CX LEAD KIT, 50CM, Model on August 12, 2026 because of spinal cord stimulation system lead body may be exposed to stress at the anchor site. It was sold in NY.
Why it was 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's recalled
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.
Quantity: 1079
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Boston Scientific Neuromodulation Corporation, Valencia, CA
- Date
- Severity
- Class I · most serious
the most serious: the product could cause serious health problems or death. - Where sold
- NY
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 - Status
- Ongoing
- Recall number
- Z-2879-2026
- Source
- U.S. Food and Drug Administration
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