Z-1697-2020Class II

Nitinol Thermocouple Electrode, 15 cm, 3m Cable -

Name: Z-1697-2020 Nitinol Thermocouple Electrode, 15 cm, 3m Cable -
Creator: Boston Scientific Neuromodulation Corporation
Published: 2019-05-30
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2019-05-30 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Neuromodulation Corporation began a recall of Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue... on 2019-05-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1697-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-30
Posted: 2020-04-10
Terminated: 2021-04-28
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: Nitinol Thermocouple Electrode, 15 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.
Product code: GXI Probe, Radiofrequency Lesion
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.
Root cause tag: labeling and UDI
FDA 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 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."
Quantity in commerce: 40 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.
Product codes and lots: TCN-15-3M; GTIN: 00813250017519; Lot Number:23049684

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1697-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1694-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-10
Z-1695-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-10
Z-1696-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-10
Z-1697-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-10
Z-1698-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-10

Product code GXI

K183177Class IINitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation / cleared 2019-03-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)