Boston Scientific Neuromodulation Corporation: INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of t

Hazard

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.

Details from the source

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. 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 Quantity: 1079 Lot/code info: Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.

UPC codes

08714729861614, 08714729861638

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.