Boston Scientific is taking unused Infinion CX leads for its spinal cord stimulator systems off the shelf, and the Food and Drug Administration has classified the removal as a Class I action, its most serious recall category.
The single most important fact for patients is one the classification label does not convey. This recall covers unused inventory only. It does not ask anyone to have an implanted lead taken out, and the company's notice to customers states plainly that already-implanted devices are not affected. For leads already in use, the company recommends continuing routine follow-up.
