The U.S. Food and Drug Administration has announced a recall of Infinion CX Lead devices manufactured by Boston Scientific due to mechanical stress concerns at the anchor site. The defect may result in inadequate electrical stimulation, requiring patients to undergo lead explantation and replacement procedures.
The recall affects spinal cord stimulator leads used for chronic pain management. Patients currently implanted with Infinion CX Lead devices may experience loss of therapeutic stimulation without warning. Boston Scientific has notified healthcare providers and is working with the FDA to manage the recall.
Patients with Infinion CX Lead implants should contact their physician or implanting center immediately to discuss their individual risk and next steps. Healthcare providers are being advised to monitor patients for signs of inadequate stimulation and consider replacement if clinically indicated. This is a developing story.
Source: Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead
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