Home / Recalls / Medical Devices
Boston Scientific Neuromodulation Corporation recalls Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peri
Recalled April 22, 2020 · FDA recall Z-1698-2020 · Boston Scientific Neuromodulation
Hazard
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. · FDA Class II
Units
43 units
Sold at
US Nationwide distribution in the states of AZ, CA,CO, FL,GA, ID,IL, IN, KY, MA, MD, MI, MO, NV, NY, OH, OK, OR, SC, TX, UT, VA, WA, and WI.
Description
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.
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.
Manufacturer(s)
Boston Scientific Neuromodulation Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →