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U.S. Department of Health and Human Services

Class 1 Device Recall Infinion CX Leads

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 Class 1 Device Recall Infinion CX Leadssee related information
Date Initiated by FirmJune 17, 2026
Date PostedAugust 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2879-2026
Recall Event ID 98974
PMA NumberP030017 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
ProductINFINION 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.
Code Information Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
FEI Number 3006630150
Recalling Firm/
Manufacturer		 Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia CA 91355-5004
For Additional Information ContactRenee Archie
508-683-4523
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 6/17/2026, removal notices were mailed and emailed to customers informing them of the following: 1) Stop further use or distribution and segregate affected product. 2) Complete and return the Reply Verification Tracking Form via email to BSCFieldActionCenter@bsci.com 3) Return affected devices to firm. 4) Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which these systems may have been transferred. Report any adverse events or quality concerns associated with use of these devices to firm via email at BSCComplaints@bsci.com This removal of unused Infinion CX Leads is part of the planned transition to the next generation lead (Infinion Pro).
Quantity in Commerce1079
DistributionUS: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LGW
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