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The FDA is aware that Boston Scientific has issued a letter to affected customers recommending all unused Infinion CX Leads be removed from where they are used or sold. This action does not affect the devices that have already been implanted.
Boston Scientific stated that the Spinal Cord Stimulator (SCS) System lead body may experience mechanical stress at the anchor site, which may result in high impedance measurements or lead fractures. Abnormal impedance measurement may lead to inadequate stimulation and/or additional intervention, including lead explant and replacement.
As of May 27, 2026, Boston Scientific has reported 1,081 serious injuries and no deaths associated with this issue.
This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Boston Scientific at BSCComplaints@bsci.com.
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