BSX · News · 20260904N
Product Safety Recall
BOSTON SCIENTIFIC CORP · 2026-09-04 · Importance 47 · Surprise 60 · In source text
Boston Scientific issued a Class I FDA recall for unused Infinion CX Leads used in its Spinal Cord Stimulator System. The recall addresses a fracture risk that can cause high impedance or loss of stimulation. The report cited 1,081 serious injuries associated with mechanical stress and lead fractures, although no deaths were reported. Healthcare professionals were instructed to immediately withdraw and return affected inventory.
Key facts
- Boston Scientific issued a Class I recall for its Infinion CX Lead, a component of its Spinal Cord Stimulator System, due to fracture risk. source
- The FDA safety recall for the Infinion CX Lead targets unused inventory and mandates healthcare professionals to immediately withdraw and return all affected products. source
- The Infinion CX Lead recall follows 1,081 reported serious injuries related to mechanical stress causing lead fractures or high impedance, and no deaths have been reported. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| operating_income | negative | committed | — | Boston Scientific issued a Class I recall for its Infinion CX Lead, a component of its Spinal Cord Stimulator System, due to fracture risk. |
| assets | negative | committed | — | The FDA safety recall for the Infinion CX Lead targets unused inventory and mandates healthcare professionals to immediately withdraw and… |
| liability | negative | committed | — | The FDA safety recall for the Infinion CX Lead targets unused inventory and mandates healthcare professionals to immediately withdraw and… |