CanadaUnused Infinion™ CX Contact Lead Kit (model/catalogue number SC-2317-XX; more than 50 affected lot/serial numbers—contact the manufacturer for specifics) from Boston Scientific Neuromodulation Corporation is being voluntarily removed as part of the planned transition to the next-generation Infinion Pro lead. The action does not affect devices already implanted; for leads already in use, continued routine follow-up is recommended. Contact the manufacturer for additional information.
What's being recalled
Companies: Boston Scientific Neuromodulation Corporation, 25155 Rye Canyon Loop, Valencia, California, United States, 91355.
How to identify it
Affected products: Infinion™ CX Contact Lead Kit; Lot or serial number: More than 50 numbers, contact manufacturer.; Model or catalogue number: SC-2317-XX
The hazard
Boston Scientific is initiating a voluntary removal of unused Infinion™ CX Leads as part of the planned transition to the next generation lead (Infinion Pro). this action does not affect the devices that have already been implanted. For leads already in use, continued routine follow-up is recommended.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States