TCN™ and CSK Reusable RF electrodes
Summary
Contact the manufacturer if you require additional information.
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
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop, Valencia, California, United States, 91355
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