medical Class II Updated 2020-04-22

Boston Scientific Neuromodulation Corporation recalls Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN

Recalled Product

Nitinol Thermocouple Electrode, 5cm - 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: Nitinol Thermocouple Electrode, 5 cm; GTIN:00813250013047; Lot Numbers: 23263846 and 23263848.
View official government recall

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