Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peri

FDA device recall Z-1698-2020 · posted 2020-04-10 · Terminated

Recall details

Recalling firm

Boston Scientific Neuromodulation Corporation

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.

Action taken

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."

Root cause

Error in labeling

Status

Terminated

Product code

GXI

Quantity affected

43 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.

Date initiated

2019-05-30

Date posted

2020-04-10

Date terminated

2021-04-28

Location

Valencia, CA

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