Product Safety Recall – Boston Scientific TCN and CSK Reusable Radiofrequency Electrodes

The National Consumer Commission (NCC) hereby informs consumers of a product recall initiated by Boston Scientific involving Thermo Couple Nitinol (TCN) and Cosman Straight Kit (CSK) Reusable Radiofrequency (RF) Electrodes. According to the supplier, the products were sold nationally between 23 November 2017 and 15 November 2024. The recall affects 293 units.

The products are intended for use in radiofrequency heat lesioning of peripheral nerve tissue only. The CSK Electrode is a stainless-steel RF electrode with a temperature-sensing thermocouple sensor at the tip, while the TCN Electrode is a Nitinol RF electrode with a temperature-sensing thermocouple sensor at the tip. Both devices are reusable and supplied non-sterile.

Boston Scientific has determined that these Electrodes may not consistently meet the expected performance levels throughout the specified 20 sterilisation cycles for re-use. This determination was based on a recent review of internal laboratory testing. Complaint data indicates that the most frequently reported issues relate to electrodes not heating, temperature-reading problems and device damage, which have led to prolonged procedures. Ninety-nine per cent (99%) of reported events were identified during the initial stage of the procedure and were resolved by replacing the electrodes. A small number of reported cases (0.15%) included unintentional burns, allergic reactions, increased pain, or the need for additional intervention to retrieve potentially unrecovered parts (0.03%).

Consumers and healthcare providers in possession of these products are advised to immediately cease further distribution or use of any remaining units linked to this recall. Boston Scientific is discontinuing the global distribution of the TCN and CSK Reusable RF Electrodes linked to this corrective action.

Questions and queries relating to this recall may be directed to: ProductRecall@thencc.org.za.