Class 2 Device Recall Cosman TCN ELECTRODE

• Date Initiated by Firm: May 30, 2019
• Date Posted: April 10, 2020
• Recall Status: Terminated on April 28, 2021
• Recall Number: Z-1695-2020
• Recall Event ID: 85085
• 510(K)Number: K183177
• Product Classification: Probe, radiofrequency lesion - Product Code GXI
• Product: Nitinol Thermocouple Electrode, 10 cm, 3m Cable - 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.
• Code Information: TCN-10-3M; GTIN: 00813250017502; Lot Numbers: 23049683, 23239528, and 23239529.
• Recalling Firm/ Manufacturer: Boston Scientific Neuromodulation Corporation; 25155 Rye Canyon Loop; Valencia CA 91355-5004
• For Additional Information Contact: Nicole Pshon; 661-949-4000
• Manufacturer 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.
• FDA Determined 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 appropriate). The Reply Verification Tracking Form enclosed with the Notice must be completed and returned even if you do not have any affected units in your inventory. 1.Complete and return the Reply Verification Tracking Form (RVTF). Complete the enclosed Reply Verification Tracking Form even if you do not have any affected product to be corrected. Follow the directions on this page and on the Reply Verification Tracking Form. Verify if the product within your inventory is affected. If so, indicate on your Verification Form the part and lot number(s) in your possession. Email or fax the Reply Verification Tracking Form to the Field Action Center as described below: Email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806 Please email or fax your Reply Verification Tracking Form(s) immediately. 2. Place the included replacement IFUs with any affected product you have identified in your inventory. IFUs originally included with affected products must be discarded."
• Quantity in Commerce: 110 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GXI and Original Applicant = Boston Scientific Corporation