Recall Monitor
Health Products

TCN™ and CSK Reusable RF electrodes

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: TCN™ and CSK Reusable RF electrodes
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
TCN™, NitinolAll lots.TCN-15-3M
TCN™, NitinolAll lots.TCN-10-3M
TCN™, NitinolAll lots.TCN-5-3M
TCN™, NitinolAll lots.TCN-20-3M
TCN™ ElectrodeAll lots.TCN-20
TCN™ ElectrodeAll lots.TCN-15
TCN™ ElectrodeAll lots.TCN-5
TCN™ ElectrodeAll lots.TCN-10
CSK ElectrodeAll lots.CSK-TC10
CSK ElectrodeAll lots.CSK-TC15-3M
CSK ElectrodeAll lots.CSK-TC20
CSK ElectrodeAll lots.CSK-TC5-3M
CSK ElectrodeAll lots.CSK-TC5
CSK ElectrodeAll lots.CSK-TC10-3M
CSK ElectrodeAll lots.CSK-TC15

Issue

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.

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