Nitinol Thermocouple Electrode — Class II medical device recall Z-1694-2020
Terminated recall by Boston Scientific Neuromodulation Corporation, reported 2020-04-22, distributed nationwide. The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the
| Recall number | Z-1694-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Neuromodulation Corporation, Valencia, CA, United States |
| Recall initiated | 2019-05-30 |
| Classified | 2020-04-10 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 437 units |
| UPC / GTIN / UDI-DI | 00813250013054 |
| Lot numbers | 23045871, 23049691, 23049693, 23049695, 23131523, 23131525, 23155050, 23155052, 23176308, 23213325, 23213326, 23235460, 23235463 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1694-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.