FDA Expands Recall of Boston Scientific Infinion CX Lead to Additional Model Codes
The FDA has expanded its most serious type recall of the Infinion CX Lead to include additional model codes, citing risk of serious injury or death.
4 reports on this incident · first at Sep 3, 2026, 5:11 p.m. ET
This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.
We last searched for new coverage of this at Sep 3, 2026, 5:39 p.m. ET — checked 58 min ago.
Earlier reports
Sep 3, 2026, 5:22 p.m. ET
FDA Reclassifies Boston Scientific Infinion CX Lead Recall as Most Serious Type
The U.S. Food and Drug Administration (FDA) has reclassified the recall of Boston Scientific's Infinion CX Lead as the most serious type, according to an agency notice. The change means the device may cause serious injury or death if use continues, the FDA reported.
The recall, initiated June 17, 2026, covers specific model codes including SC-2317-50, M365SC2317500, 08714729861614, SC-2317-70, M365SC2317700, and 08714729861638. The FDA reported 1,081 serious injuries and no deaths associated with the device.
The agency said the Spinal Cord Stimulator (SCS) System lead body may experience mechanical stress at the anchor site, which may result in high impedance measurements or lead fractures. The FDA instructed users to immediately stop further use or distribution, segregate affected product, and return it to Boston Scientific.
Sep 3, 2026, 5:17 p.m. ET
FDA Reports 1,081 Serious Injuries Linked to Boston Scientific Infinion CX Lead Recall
The U.S. Food and Drug Administration (FDA) has reported 1,081 serious injuries and no deaths associated with the Boston Scientific Infinion CX Lead, a spinal cord stimulator component the agency recalled on June 17, 2026, according to an FDA notice.
The FDA classified the recall as its most serious type, stating that continued use of the device may cause serious injury or death. The agency said the lead body may experience mechanical stress at the anchor site, which may result in high impedance measurements or lead fractures.
The recall affects specific model codes including SC-2317-50, M365SC2317500, 08714729861614, SC-2317-70, M365SC2317700, and 08714729861638. The FDA instructs users to immediately stop further use or distribution, segregate affected product, and return it to Boston Scientific.
Sep 3, 2026, 5:11 p.m. ETFirst report
FDA Recalls Boston Scientific Infinion CX Lead Over Risk of Serious Injury or Death
The U.S. Food and Drug Administration (FDA) has announced a recall of the Infinion CX Lead, a component of the Spinal Cord Stimulator (SCS) System, manufactured by Boston Scientific. The recall was initiated on June 17, 2026, and is classified as the most serious type, according to the FDA.
The FDA reports that the device may cause serious injury or death if use continues. The reason for the recall is that the lead body may experience mechanical stress at the anchor site, which may result in high impedance measurements or lead fractures. The FDA has reported 1,081 serious injuries and no deaths associated with the device.
The affected product includes model numbers SC-2317-50, SC-2317-70, and associated catalog numbers M365SC2317500, M365SC2317700, and 08714729861614, 08714729861638. The FDA instructs users to immediately stop further use or distribution and segregate affected product, and to return the product to Boston Scientific.
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- Version 13 Sept 2026, 21:22current
First published.
- Version 13 Sept 2026, 21:11current
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- Version 13 Sept 2026, 21:17current
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- Version 13 Sept 2026, 21:22current
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