FDA-Device2020-04-22Class II
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
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.
Sold states
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.
Affected count
43 units
Manufactured in
25155 Rye Canyon Loop, Valencia, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1698-2020More Boston Scientific Neuromodulation Corporation recalls
- FDA-Device2026-06-17Boston Scientific CSK Electrodes recalled for substandard performance
- FDA-Device2026-06-17Boston Scientific Clik X Anchor recalled for sterility assurance concerns
- FDA-Device2026-06-17Boston Scientific TCN Electrodes recalled for substandard performance
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief