FDA recall Z-1698-2020

Boston Scientific Neuromodulation Corporation · Class II · device

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.

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2019-05-30
Report date
2020-04-22
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Valencia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1698-2020