Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Nitinol Radiofrequency Thermocouple (TCN) Electrodes. The affected products are identified as following:

• Product Description: A) Nitinol Thermocouple Electrode, 10 cm; B) Nitinol Thermocouple Electrode, 10 cm, 3m Cable; C) Nitinol Thermocouple Electrode, 15 cm; D) Nitinol Thermocouple Electrode, 15 cm, 3m Cable; E) Nitinol Thermocouple Electrode, 5 cm
• Part Numbers (UPN): A) TCN-10; B) TCN-10-3M; C) TCN-15; D) TCN-15-3M; E) TCN-5
• GTIN: A) 00813250013054; B) 00813250017502; C) 00813250013061; D) 00813250017519; E) 00813250013047
• Lot Numbers: A) 23045871, 23049691, 23049693, 23049695, 23131523, 23131525, 23155050, 23155052, 23176308, 23213325, 23213326, 23235460, 23235463; B) 23049683, 23239528, 23239529; C) 23014533, 23049687, 23049688, 23192881; D) 23049684; E) 23263846, 23263848

The manufacturer is initiating a voluntary correction of the affected products due to an incorrect revision of the Instructions for Use (IFUs) being packaged with the affected products. The correction affects only the part numbers (with associated lot numbers) listed above. No other products are impacted by the notification.

According to the manufacturer, it has determined that the issue poses no foreseeable risk to patient safety. The devices meet all design specifications and are expected to perform as intended.

Customers are not required to return product to the manufacturer. Replacement IFUs have been included in the notification package.

According to the local supplier, the affected products are not distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 10 June 2019