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.
Check against the official notice below — it lists the full affected range.
Boston Scientific Neuromodulation Corporation voluntarily corrected 437 units of its Cosman TCN Electrode (a device used for radiofrequency heat lesioning of peripheral nerve tissue) because incorrect versions of the Instructions for Use were packaged with the products. The affected devices were distributed nationwide across 23 states, including Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington, and Wisconsin, under lot numbers 23045871, 23049691, 23049693, 23049695, 23131523, 23131525, 23155050, 23155052, 23176308, 23213325, 23213326, 23235460, and 23235463.
The source document does not specify a remedy or actions for affected consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 437 units Lot/code info: TCN-10, GTIN:00813250013054, Lot Numbers: 23045871, 23049691, 23049693, 23049695, 23131523, 23131525, 23155050, 23155052, 23176308, 23213325, 23213326, 23235460, and 23235463.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.