United StatesINFINION CX LEAD KIT (50 cm, model SC-2317-50, material M365SC2317500; 70 cm, model SC-2317-70, material M365SC2317700; UDI-DI SC-2317-50/08714729861614 and SC-2317-70/08714729861638) used with Boston Scientific spinal cord stimulator systems is being recalled. The lead body may be exposed to stress at the anchor site, which can cause high impedance measurements or lead fractures and may result in inadequate stimulation or require additional intervention, including lead explant and replacement.
What's being recalled
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.
Recalling firm: Boston Scientific Neuromodulation Corporation, Valencia, CA, United States.
How to identify it
Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada