Boston Scientific Neuromodulation Corporation: Medical Device Recall in 2020 - (Recall #: Z-1694-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 30, 2019

Date Posted: April 22, 2020

Recall Number: Z-1694-2020

Event ID: 85085

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.

Status: Terminated

Product Quantity: 437 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated