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.
Class I · Ongoing
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.
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Affected lots / codes — check yours against thisModel/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
- Recalling firm
- Boston Scientific Neuromodulation Corporation, Valencia, CA
- Classification
- Class I (most serious — risk of serious harm)
- Status
- Ongoing
- 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
- Recall initiated
- June 17, 2026
- Classified
- August 5, 2026
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2879-2026%22
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2879-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →