FDA Device recall Z-1695-2020
Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral…
- FDA Device
- Class II
- terminated
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral… by Boston Scientific Neuromodulation, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1695-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-30 |
| Published | 2020-04-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | US |
Product
Nitinol Thermocouple Electrode, 10 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
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.
Identifiers
| code_info | TCN-10-3M; GTIN: 00813250017502; Lot Numbers: 23049683, 23239528, and 23239529. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1695-2020%22
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