INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70,
Summary
The FDA issued a Class I for INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINI by Boston Scientific Neuromodulation Corporation. Reason: 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.
Details
Source
Device Recall
External ID
Z-2879-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
Quantity Affected: 1079
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-17
Company
Valencia, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Boston Scientific Neuromodulation Corporation has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Neuromodulation Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Neuromodulation Corporation have FDA actions?
Boston Scientific Neuromodulation Corporation has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2879-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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