Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1698-2020 — Nitinol Thermocouple Electrode, 5cm - 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.

U.S. FDA — Device Enforcement · United States · 2019-05-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1698-2020
Date of alert
2019-05-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Neuromodulation Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00813250013047
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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