Tag: infinion_cx_leads

FDA Issues Class I Recall for Boston Scientific Spinal Cord Stimulator Leads

3 Sep 2026 4:18 p.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Boston Scientific's unused Infinion CX Leads, part of Spinal Cord Stimulator Systems. Mechanical stress can cause lead fractures, leading to inadequate stimulation and 1,081 reported serious injuries. This recall affects only…

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