Boston Scientific removed unused Infinion CX leads for spinal cord stimulators after reports of 1,081 serious injuries and zero deaths associated with an issue involving the devices.
The FDA identified the recall as the most serious type. Boston Scientific sent affected customers a June 17, 2026, letter recommending they immediately stop use and distribution of affected products and return them to Boston Scientific.
Boston Scientific said the spinal cord stimulator system lead body may experience mechanical stress at the anchor site, potentially resulting in high impedance measurements or lead fractures. Abnormal impedance measurement may lead to inadequate stimulation and/or additional intervention, including lead explant and replacement.
The action affects unused Infinion CX lead kit devices in 50- and 70-centimeter sizes. It does not affect devices that have already been implanted.
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