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 ...
Health authorities have categorized an urgent device withdrawal by Boston Scientific Corp. BSX as the most serious class of recall available. Severe FDA Safety Recall Warning The regulatory advisory ...
A problem with the leads could cause inadequate stimulation, Boston Scientific said. In the worst case, leads may need to be removed or replaced.
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