Critical Alert
Boston Scientific Neuromodulation Corporation Recalls INFINION CX LEAD KIT
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2879-2026Medical Device
Boston Scientific Neuromodulation Corporation Recalls INFINION CX LEAD KIT
Boston Scientific Neuromodulation Corporation · Class I — Most Serious
Product Description
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.
Reason for Recall
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
US: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Boston Scientific Neuromodulation Corporation is recalling a medical device classified as Class I by the FDA — the highest risk level. The recall was initiated on June 17, 2026 affecting 1079. Spinal cord stimulation system lead body may be exposed to stress at the anchor site. It was distributed nationwide. Consumers and healthcare professionals should exercise caution and discontinue use of the recalled product. Contact the recalling firm directly for return or disposal instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Poison & Chemical Hazards.