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Nitinol Thermocouple Electrode, 10 cm - Product Usage: The… recallZ-1694-2020 · Boston Scientific Neuromodulation Corporation · initiated May 30, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Neuromodulation Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Error in labeling

What the company is doing

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: [email protected] 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."

Recall details

Recall number
Z-1694-2020
Status
Terminated
Initiated by the company
May 30, 2019
Posted by the FDA
Apr 10, 2020
Recalling firm
Boston Scientific Neuromodulation Corporation
Quantity
437 units
Product code
GXI
FDA submissions
K183177
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.

Product description

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.

Code information (models, lots, serial numbers)

TCN-10, GTIN:00813250013054, Lot Numbers: 23045871, 23049691, 23049693, 23049695, 23131523, 23131525, 23155050, 23155052, 23176308, 23213325, 23213326, 23235460, and 23235463.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 85085).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page