# FDA recall Z-1697-2020

> **Boston Scientific Neuromodulation Corporation** · Class II · device recall initiated 2019-05-30.

## 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.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1697-2020
- **Recalling firm:** Boston Scientific Neuromodulation Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-30
- **Report date:** 2020-04-22
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valencia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1697-2020

## Citation

> AI Analytics. FDA recall Z-1697-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1697-2020. Source: US FDA. Licensed CC0.

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