CanadaBoston Scientific Neuromodulation Corporation’s TCN™ and CSK reusable RF electrodes (all lots; models include TCN-5, TCN-10, TCN-15, TCN-20, TCN-5-3M, TCN-10-3M, TCN-15-3M, TCN-20-3M, CSK-TC5, CSK-TC5-3M, CSK-TC10, CSK-TC10-3M, CSK-TC15, CSK-TC15-3M, CSK-TC20) are affected. The devices may not consistently meet expected performance through the specified 20 sterilization cycles based on internal laboratory testing; 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: TCN™, Nitinol; Lot or serial number: All lots.; Model or catalogue number: TCN-15-3M
Affected products: TCN™, Nitinol; Lot or serial number: All lots.; Model or catalogue number: TCN-10-3M
Affected products: TCN™, Nitinol; Lot or serial number: All lots.; Model or catalogue number: TCN-5-3M
Affected products: TCN™, Nitinol; Lot or serial number: All lots.; Model or catalogue number: TCN-20-3M
Affected products: TCN™ Electrode; Lot or serial number: All lots.; Model or catalogue number: TCN-20
Affected products: TCN™ Electrode; Lot or serial number: All lots.; Model or catalogue number: TCN-15
Affected products: TCN™ Electrode; Lot or serial number: All lots.; Model or catalogue number: TCN-5
Affected products: TCN™ Electrode; Lot or serial number: All lots.; Model or catalogue number: TCN-10
Affected products: CSK Electrode; Lot or serial number: All lots.; Model or catalogue number: CSK-TC10
Affected products: CSK Electrode; Lot or serial number: All lots.; Model or catalogue number: CSK-TC15-3M
Affected products: CSK Electrode; Lot or serial number: All lots.; Model or catalogue number: CSK-TC20
Affected products: CSK Electrode; Lot or serial number: All lots.; Model or catalogue number: CSK-TC5-3M
Affected products: CSK Electrode; Lot or serial number: All lots.; Model or catalogue number: CSK-TC5
Affected products: CSK Electrode; Lot or serial number: All lots.; Model or catalogue number: CSK-TC10-3M
Affected products: CSK Electrode; Lot or serial number: All lots.; Model or catalogue number: CSK-TC15
The hazard
Boston Scientific has determined that the TCN™, and CSK reusable RF electrodes may not consistently meet the expected performance levels throughout the specified 20 sterilization cycles for re-use. This determination was based on recent review of internal laboratory testing.
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