FDA confirmed a Class I recall on September 3 covering Boston Scientific Infinion CX leads used in spinal cord stimulation systems. The company reported 1,081 serious injuries as of May 27, 2026.
Mechanical stress at the anchor site can produce high impedance measurements or fracture the lead body. Either shows up as inadequate stimulation, and correcting it can mean surgery to replace the lead. The action reaches roughly 1,079 unused leads. Implanted patients stay on routine clinical follow-up, with no extra monitoring recommended.
Boston Scientific sent its advisory letter in June and FDA updated the recall database on August 5. The company is moving customers to next-generation Infinion Pro leads, and litigation over spinal cord stimulator malfunctions was centralized into a single case in June.
About 1,079 leads pulled from shelves against 1,081 serious injuries is the shape of a failure that lives in the installed base rather than in inventory. The correction clears distribution, which is the part a recall can reach, while the risk sits with patients already carrying the lead. Anchor design and the stress it puts on a lead body is a chronic implant question, and it belongs in your fatigue testing long before it shows up in complaint files.