Practical implication
All customers handling Infinion CX Leads must stop using these devices, segregate them, and return them to Boston Scientific as per the recall protocol communicated on June 17, 2026.
Boston Scientific has initiated a recall of the Infinion CX Lead, a component of spinal cord stimulators, due to reports of mechanical stress that may cause high impedance measurements and lead fractures. The FDA has classified this recall as serious and recommends immediate cessation of use and distribution of the affected products, which may result in serious injury or death.
What changed: Immediate stop of use and distribution of all unused Infinion CX Leads as part of the recall action.
Why it matters: The recall affects patient safety, with over 1,000 serious injuries reported related to the Infinion CX Lead's failure, necessitating urgent attention and corrective measures.
Practical implication: All customers handling Infinion CX Leads must stop using these devices, segregate them, and return them to Boston Scientific as per the recall protocol communicated on June 17, 2026.
View original source
- Source: FDA - MedWatch Safety Alerts RSS
- Published at source: 2026-09-03T00:00:00.000Z
- Discovered by monitor: 2026-09-03T21:47:54.030Z
Published from the regulator source ingestion pipeline after PV impact triage.
