medical Class II Updated 2020-04-22

Boston Scientific Neuromodulation Corporation recalls Nitinol Thermocouple Electrode, 10 cm - Product Usage: The T

Recalled Product

Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.

Hazard / Issue

The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: TCN-10, GTIN:00813250013054, Lot Numbers: 23045871, 23049691, 23049693, 23049695, 23131523, 23131525, 23155050, 23155052, 23176308, 23213325, 23213326, 23235460, and 23235463.
View official government recall

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