The US Food and Drug Administration (FDA) has issued an alert over Boston Scientific’s recall of a lead kit used with its spinal cord stimulator (SCS) system at a time when the company and other medtech industry players are facing lawsuits over SCS systems malfunctioning.
In a letter sent to customers on 17 June, Boston said the body of its Infinion CX leads, which are compatible with its SCS systems for relieving chronic pain in the back and limbs, including Spectra WaveWriter and WaveWriter Alpha, may experience “mechanical stress at the anchor site”, an issue that may result in high impedance measurements or lead fractures.
These abnormal impedance measurements may lead to inadequate stimulation and/or additional intervention, including lead explant and replacement, the company stated as per the FDA alert. SCS is a form of neuromodulation used for treating chronic, severe nerve pain in the trunk, arms, or legs when conservative treatments have failed.
As of 27 May, Boston Scientific has reported 1,081 serious injuries and no deaths associated with this issue.
While the action does not affect SCS devices that have already been implanted, Boston now recommends that all unused Infinion CX leads be removed from where they are used or sold.
Boston’s recall comes at a time in which the company, alongside other players in the medtech industry with SCS systems, including Medtronic and Abbott, are facing lawsuits regarding device failure, shocks, and lack of pain relief.
A series of lawsuits pertaining to Boston’s SCS systems were formally centralised into a single federal multidistrict litigation (MDL) on 5 June 2026 for coordinated proceedings.
Meanwhile, in August 2026, Abbott opposed the creation of a proposed MDL seeking to consolidate 23 personal injury lawsuits involving its SCS systems into a single proceeding in the Central District of California.
According to GlobalData analysis, the global neurology devices market, of which SCS systems are a part, is projected to reach a valuation above $25bn in 2034. Meanwhile, a recent report from GlobalData forecasts that the SCS market will be worth $3.5bn in North America in 2033.
