FDA expands Boston Scientific spinal cord stimulator lead recall
The FDA has expanded a recall of Boston Scientific spinal cord stimulator leads, now covering Infinion CX, Spectra WaveWriter, and WaveWriter Alpha devices.
3 reports on this incident · first at Sep 4, 2026, 10:53 a.m. ET
Earlier reports
Sep 4, 2026, 10:56 a.m. ET
FDA reports 1,081 serious injuries tied to Boston Scientific spinal cord stimulator leads
The U.S. Food and Drug Administration (FDA) has reported 1,081 serious injuries and no deaths associated with Boston Scientific's Infinion CX leads, according to Medical Device Network. The leads are part of the company's spinal cord stimulator (SCS) system.
The FDA identified a hazard involving mechanical stress at the anchor site, which may result in high impedance measurements or lead fractures. The agency has advised that all unused Infinion CX leads be removed from where they are used or sold.
The affected products include the Infinion CX, Spectra WaveWriter, and WaveWriter Alpha brands. Boston Scientific is the firm associated with these devices.
Sep 4, 2026, 10:53 a.m. ETFirst report
FDA warns of Boston Scientific spinal cord stimulator lead risks
The U.S. Food and Drug Administration (FDA) has issued a safety alert concerning certain spinal cord stimulator (SCS) leads made by Boston Scientific, according to a report by Medical Device Network. The affected products are the Infinion CX, Spectra WaveWriter, and WaveWriter Alpha lead kits, used with the company's SCS system. The FDA reported 1,081 serious injuries and no deaths associated with these devices.
The alert cites mechanical stress at the anchor site as a potential issue, which may lead to high impedance measurements or lead fractures. As a remedy, the FDA has advised that all unused Infinion CX leads be removed from where they are used or sold.
The FDA's action is based on reports of injuries; the underlying cause of the mechanical stress has not been determined.
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Sources
- Boston Scientific’s SCS leads linked to 1,081 serious injuries in FDA alertmedicaldevice-network.com
Revision history
- Version 14 Sept 2026, 15:00current
First published.
- Version 14 Sept 2026, 14:53current
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- Version 14 Sept 2026, 14:56current
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