TCN™ and CSK Reusable RF electrodes
Last updated
Summary
Product
TCN™ and CSK Reusable RF electrodes
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| TCN™, Nitinol | All lots. | TCN-15-3M |
| TCN™, Nitinol | All lots. | TCN-10-3M |
| TCN™, Nitinol | All lots. | TCN-5-3M |
| TCN™, Nitinol | All lots. | TCN-20-3M |
| TCN™ Electrode | All lots. | TCN-20 |
| TCN™ Electrode | All lots. | TCN-15 |
| TCN™ Electrode | All lots. | TCN-5 |
| TCN™ Electrode | All lots. | TCN-10 |
| CSK Electrode | All lots. | CSK-TC10 |
| CSK Electrode | All lots. | CSK-TC15-3M |
| CSK Electrode | All lots. | CSK-TC20 |
| CSK Electrode | All lots. | CSK-TC5-3M |
| CSK Electrode | All lots. | CSK-TC5 |
| CSK Electrode | All lots. | CSK-TC10-3M |
| CSK Electrode | All 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop, Valencia, California, United States, 91355
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82046
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