Recall Z-1694-2020 ยท GXI Probe, Radiofrequency Lesion
Boston Scientific Neuromodulation Corporation
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.
| Date | Apr 10, 2020 (initiated May 30, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Error in labeling |
| Action | The firm reported that they have included replacement IFUs with the notification package and these were sent Fedex 2 Day mail. The following was included in the firm's notification letter: "Your local Sales Representative can answer any questions that you may have regarding this correction. Please pass this notice to any healthcare professional from your organization who needs to be aware and to any organization where the potentially affected devices have been transferred (if appropriate). Please provide details of any affected devices that have been transferred to other organizations (if a |
| Quantity | 437 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183177 | Nitinol Thermocouple (TCN) Electrode Boston Scientific Corporation, Mar 8, 2019 |